BesTech Consulting Services
Nicolaas C. Besseling, Principal
Devices, Drugs, Biologics/Biotechnology
FDA Consulting, Quality Systems Implementation, 510(k) submissions, CE-marking,
ISO 13485 implementation, ISO 14971 support.
How long in business? 12 years
PH: 949-466-7472
FX: 949-448-0312
EM: bestechconsulting@cox.net
WS: http://www.bestechconsulting.biz
Last update: May 2, 2008
Back to List
Biologics Consulting Group, Inc.
Gil Salud, MS, Senior Consultant
Devices, Drugs, Biologics/Biotechnology
Biologics Consulting Group, Inc. (BCG) is a team of consultants who provide national and
international regulatory and product development advice on the development and commercial
production of biological, drug and device products. Our staff consists of experts in regulatory
affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections,
statistics, program management, and clinical trial design and evaluation. Many of our consultants
are former CBER, CDER, and CDRH reviewers, certified FDA inspectors, and senior scientists from
the biotechnology industry.
BCG specializes not only in the preparation and review of CBER regulatory applications (INDs and
BLAs) as well as the inspection/audit of biologics manufacturing facilities but also in similar
regulatory activities for drugs, device and combination products. Because of our familiarity with
FDA expectations, we have an excellent reputation at the Agency for filing high-quality, easily
reviewable applications.
Services offered by the west coast office include:
# Regulatory support and advice
# Regulatory submission development and compilation
# Regulation and policy development for cell and tissue-based therapy products
# Program management of biotech products
# Clinical development advice and assistance
# Quality Systems development and assessment
# Biologics manufacturing operations advice and support
# Identifying, qualifying, and managing contract manufacturing and testing organizations
# Quality Auditing
# Due diligence
How long in business? 15 years
PH: 408-338-7381
EM: gsalud@bcg-usa.com
WS: http://www.bcg-usa.com
Last update: January 10, 2009
Back to List
BioSolve
Andrea Friedman, MS - President
Devices,
Drugs, IVDs, Biologics/Biotechnology
Ms. Friedman is an independent consultant and medical writer with extensive experience in many
aspects of the Clinical Affairs arena. She provides clients, from start-ups through established
companies, quality GCP and medical writing services. Areas of expertise include:
• Designing and writing clinical research protocols and case report forms
• Researching and writing literature reviews and summaries
• Summarizing clinical and preclinical data for FDA submissions
• Conducting GCP Audits
• Monitoring clinical studies
• Writing clinical SOPs
• Preparing and presenting GCP seminars
• Providing support for the development of clinical operations departments, include GCP training
How long in business? 20 years
PH: 805-498-6615
FX: 805-498-6615
EM: biosolve.andrea@gmail.com
Last update: January 18, 2007
Back to List
BQC Consulting
Nevine Erian, MSQA, MBA, CQE
Devices, IVDs, Biologics/Biotechnology
BQC Consulting provides biotech firms value-added compliance,
integrating business needs, regulatory requirements and processes.
We develop and implement non-taxing sustainable compliance programs for
start-up and established biotech companies.
Our services are founded on the following tenets: due diligence,
integrity, and a passion for excellence.
Services Offered:
-
Developing, improving and deploying FDA & ISO compliant quality systems
-
ISO 13485:2003 conversion
-
MDD compliance and CE Marking
-
Risk Management throughout product life cycle
-
Product and process improvements
-
ISO & QSR Training programs
-
Performing regulatory due diligence for OEM suppliers & acquisitions
-
Technical writing of policies and procedures
-
Representing clients during an FDA Inspection
-
Mitigation of 483 and Warning Letter observations
-
FDA 510(K) submissions
-
Facility registrations
How long in business? 18 years
PH: 949-370-7155
FX: 949-240-8829
EM: nevine@bqcconsulting.com
WS: www.bqcconsulting.com
Last update: May 4, 2008
Back to List
Bukirin & Associates
Ofelia F. Bukirin-Druce, Principal
Devices, Drugs, IVD, Biologics/Biotechnology
BUKIRIN & ASSOCIATES is a Pharmaceutical/BioPharmaceutical consulting and
services group specializing in cGMP/GLP/GCP Compliance, Quality Control, Quality
Assurance, and Validation.
BUKIRIN & ASSOCIATES is a team of highly qualified, seasoned, and multi-skilled
bio-pharmaceutical professionals with extensive hands-on and management experience
in various Pharmaceutical and BioPharmaceutical manufacturing facilities in the U.S.
Our Services include but are not limited to:
·Preparation for Pre-Approval Inspection (PAI) Readiness
·Mock PAI Inspections
·GMP Training
·Internal Audits (GMPs, GLPs, GCPs)
·Vendor Audits (international and domestic suppliers, contract labs, contract manufacturers,
service providers)
·CGMP Audits of Plasma Centers, Blood Banks, Donor Centers
·QA/QC Systems Design,
SOP writing, and Implementation: CAPA; Change Control; MRB/Non-Conforming Materials;
Deviation/Variance/Incidents Management; OOS/Failure Investigations; Root Cause Analysis;
Product Complaints; Annual Product Review; Vendor Program; Raw Material Program; Equipment
Qualification, Calibration, and Maintenance
·Lot Release and Batch Records Review/Audits
·Design and Management of Stability Program
·Environmental Monitoring Program
·Audit of validation documents - QA/QC/Manufacturing (equipment, process, utilities, facilities,
test methods validation)
·Performance and Closure of Product Related Investigations
·Preparation of Validation Masterplan ·Preparation of CMCs, DMFs, Regulatory Submissions
·Audit of Regulatory Submissions and Supporting Documentation
·Contract QA
·Review of Analytical Test Records for Lot Release
-Internal System and Facility Audits
-International and Domestic Supplier Audits
-Qualification Audits of Contract Manufacturers (Drug Product Mfg./Filling /Packaging
/Labeling/Warehouse and Distribution Centers)
-Audits of Contract Testing Laboratories
-Review/Audit of Validation Reports and Protocols (Facility, Equipment, Process, Cleaning, Test
Methods, Stability, Lab Instrumentation)
-Writing of SOPs/QA Systems
-Audit and Preparation of Raw Material Specifications
-QA/QC Systems Benchmarking.
How long in business?: 9 years
PH: 949-888-7423
FX: 949-888-7423
EM: obukirin@aol.com
Last update:
Back to List
ClinReg Consulting Services, Inc.
Judy Gordon, D.V.M., President and Founder
Devices, Drugs, IVD, Biologics/biotechnology
ClinReg Consulting Services, Inc. was founded in 1998, with the goal of
supporting medical device and pharmaceutical companies with strategic
clinical, regulatory and statistical consulting services directed toward FDA
approval as well as international product registrations.
Services include:
1. Clinical and regulatory development plans for novel technologies
2. Clinical trial design
3. Clinical database development in compliance with FDA requirements and
data management
4. Statistical analyses of clinical data for clinical reports,
submissions, publications, presentations
5. Pre-IDE and pre-IND meetings with FDA
6. IDE and IND submissions
7. HUD/HDE submissions
8. Premarket notifications
9. PMAs, NDAs
10. International registrations (Canada, Australia, EU, Pacific Rim, Latin
America)
Specialized services include preparation for Advisory Committee review of
PMAs/NDAs, management of Data Safety and Monitoring Boards (DSMBs), review and
reporting of adverse events, preparation for FDA bioresearch monitoring
inspections and management of FDA QSR inspections. In addition to regulatory
submissions and the associated documents, ClinReg prepares white papers,
publications for peer-review and other scientific or technical documents.
Client companies represent all major medical specialties, including urology,
gynecology, neurology, neurointerventional radiology, dermatology, ENT,
cardiology, gastroenterology, general surgery, plastic surgery, and
ophthalmology.
Judy F. Gordon, D.V.M.
(949) 715-0609 office
(949) 715-0610 fax
judy@clinregconsulting.com
www.clinregconsulting.com
Last update: June 8, 2009
Back to List
Commissioning Agents, Inc.
Jane Conant, Marketing & Sales Support Manager
Premier provider of commissioning and qualification services worldwide, including factory
inspections, construction QA oversight, PAT, tech transfer, process validation, and
regulatory compliance consulting.
Work Ph: (317) 271-2550
Fax: (317) 271-6097
jane.conant@cagents.com
www.commissioningagents.com
How long providing service: 13 years
Last update: June 8, 2009
Back to List
Emergo Group, Inc.
Rene van de Zande, President & CEO
Emergo Group assists medical device and IVD companies with regulatory affairs, quality
assurance and distributor search consulting. Since 1997, we have assisted more than
1,000 companies worldwide. Our services include:
UNITED STATES (Offices in CA, TX, MI, FL)
> FDA 510(k) submissions
> GMP implementation, auditing and training
> Classification consulting
> Form 483 and Warning Letter recovery
> ISO 14971:2007 risk management
> Validation consulting
> US distributor search
EUROPE (Office in The Netherlands)
> Authorized Representative - EC REP
> CE Marking consulting
> Technical File preparation and review
> ISO 13485:2003 implementation, auditing and training
> EU distributor search and qualification
JAPAN (Office in Tokyo)
> Designated Marketing Authorization Holder (D-MAH)
> JPAL compliance
> MHLW Ordinance #169 consulting
> Seihin Hyojun Sho file creation
> Medical device reimbursement
> STED preparation
CHINA (Office in Beijing)
> SFDA medical device approvals
> Legal Agent and After Sales Agent representation
> CCC Mark certification consulting
> Clinical trial research
CANADA (Office in Vancouver)
> Medical Device Establishment License applications
> ISO 13485:2003 modification
> CMDR consulting
> ISO 13485 training
> Distributor search and qualification
AUSTRALIA (Office in Sydney)
> TGA Sponsor representation
> Medical device and IVD registration
> STED preparation
> Medical distributor search
How long in business? Since 1997
PH: 800-956-6588
FX: 512-327-9997
EM: rvz@emergogroup.com
WS: http://www.EmergoGroup.com
Last updated: June 3, 2008
Back to List
ENTEREY, INC.
Jim Anthony, Director
Devices, Drugs, IVD, Biologics/Biotechnology
ENTEREY, the premier consulting specialists for the medical device, biotech and
pharmaceutical industries, is an Orange County based firm established in 2002. We
strive to exceed the expectations of our life sciences clients by focusing intently on
their needs to successfully deliver innovative solutions. Our primary areas of focus
and documented expertise encompass:
• Facility Start-Up
• Merger Acquisition Transition / Integration
• Technology Transfer
• Business Process Improvement
• Strategic Planning / Workforce Optimization
• Inspection Preparation and Readiness
• Regulatory Compliance
• Quality Audits
• Risk Management
• Metrics
• ISO Certification Preparation
• IT Implementations
• Validation – Software / Process / Equipment
• Quality Assurance / Quality Control
• Supply Chain Management / ERP
• Human Resources / Training
• Clinical Development / Trials
• Change Management
• Lean Six Sigma
• Project Management
• Custom On-Site Seminars
Our world-class approaches to optimize solutions for our clients differentiate us from the
competition. Contact us today to discuss your current needs.
How long in business? 7 years
PH: 949-275-1148
FX: 949-705-6688
EM: jim.anthony@enterey.com
WS: www.enterey.com
Last updated: January 26, 2009
Back to List
Global Language Solutions
Inna Kassatkina, President
Devices, Drugs, IVD, Biologics/Biotechnology
Global Language Solutions® (GLS) is a full-service ISO 9001:2000
certified translation company delivering solutions in over 100 languages to
increase its clients' multicultural and international market share. GLS
provides document translations, website localization, cultural review,
linguistic validation, multilingual graphic design services,
conference interpreters, simultaneous interpretation equipment, voice-overs,
regulatory and globalization consulting.
The types of documents we translate on a daily basis include product
marketing materials, clinical protocols, informed consent forms, case
report forms, instructions for use, labeling, patents, corporate
compliance documents, patient education materials, press releases, and much
more. Our language translation experts have long-term medical and
regulatory affairs background, and translation memory tools we use provide
significant cost savings to our clients.
Since 1994, GLS has worked with the world’s leading pharmaceutical,
medical devices, biomedical, and healthcare organizations. The company has
been contracted by sponsors as well as CROs, IRBs, and other clinical
research organizations.
The types of materials GLS translates on a daily basis include:
• Informed Consent Forms (ICFs)
• Clinical Trial Protocols
• Labeling and Inserts
• Scientific Patents and Technical Articles
• Consumer / Patient Education Materials
• Advertising and Marketing Copy
• Voice-overs and IVRS Prompts
• Patient-Reported Outcomes (PROs)
Our language professionals have long-term medical and regulatory
affairs backgrounds, and translation memory tools we use provide significant
cost savings to our clients.
GLS is a corporate member of the American Translators Association
(ATA), Drug Information Association (DIA), Association of Clinical Research
Professionals (ACRP), Regulatory Affairs Professional Society (RAPS),
and American Public Health Association (APHA). Excellent industry
references are available upon request.
GLS is a WBENC-certified women's business enterprise (WBE) based in
Aliso Viejo, California. For more information, visit
www.globallanguages.com or call +1-949-798-1400.
How long in business? 11 years
PH: 949-798-1400
FX: 949-798-1410
EM: info@globallanguages.com
WS: www.globallanguages.com
Last updated: May 8, 2008
Back to List
ICON Development Solutions
Jeff Miller, Principal Consultant
Drugs, Biologics/biotechnology
With expertise in clinical pharmacology, regulatory affairs, pharmacokinetics, pharmacometrics,
biopharmaceutics, and bioanalytical, ICON Development Solutions specializes in the strategy,
management and execution of product development and early phase clinical development.
Jeff P. Miller rejoins ICON Development Solutions as Principal Consultant. He was previously
with ICON (Globomax) from 2003-2005 as VP, Regulatory Affairs & QA. Mr. Miller served as VP
of Regulatory Affairs & QA for Depomed from 2005-2007. Prior to that, Mr. Miller was Executive
Director, Regulatory Affairs and Compliance for DURECT Corporation, a drug delivery technology company.
His career also includes several senior level positions at biotechnology companies, including
Clingenix/Research Services Inc., from 1999-2001, CV Therapeutics, Inc., from 1997-1999 and, from 1993-1997,
Matrix Pharmaceutical, Inc., where he helped to establish the regulatory and compliance functions in-house to support
clinical trials and commercial registration and supply. Earlier in his career, Mr. Miller spent 17 years
at Syntex Research, Inc. in basic research, then Human Pharmaceutical Regulatory Affairs and Compliance.
Mr. Miller holds a B.A. in Biological Sciences from the University of California, Santa Barbara.
How long in business? 20+ years
PH: 650-620-2180
FX: 650-620-2274
EM: millerJ@iconus.com
WS: http://www.icondevsolutions.com
Last updated: October 24, 2007
Back to List
ISOMillennium Consulting
Services, Inc.
Serrah Namini, Principal
Devices, Drugs, IVD, Biologics/biotechnology
Provide optimum results for medical device industry with their regulatory and
quality compliance, such as:
* FDA and Canadian product submissions
* Factory set-up to meet QSR and ISO
* Design control activities
* Audits
* Provide guidance and support during FDA inspections and follow-ups
How long in business? 15 years
PH: 949-305-8129
EM: naminib@yahoo.com
Last updated: April 13, 2006
Back to List
JL Fralick Consulting, Inc.
Julie L. Fralick, President
Devices, Drugs, Biologics/biotechnology
JL Fralick Consulting was formed to provide high quality advice and professional services
to the biotechnology, pharmaceutical and medical device industries. A full range of
domestic and international services are provided for clinical research and regulatory
submissions for both large companies and small start-ups.
Some Services Offered:
· Writing PMAs, Supplements, IDEs, Annual/Final Reports,
510(k)s, BLAs, CE Mark Technical Files
· Set-up Data Safety Monitoring Boards, Medical Advisory Boards, and Diagnostic
Core Labs
· Adverse Event Reporting
· Standard Operating Procedure Development
· Preparation of Clinical Protocols, CRFs, CRF Guidelines, and Informed Consent Forms
· Preparation of Investigator’s Brochure
· Development of Investigational Plan
· Non-clinical laboratory testing
· IRB Submissions as well as IRB and Investigator Interaction
· Clinical Research and Funding Contracts
· Identification and Qualification of Investigators
· Investigator and Research Staff Training
· Domestic and International Clinical Trial Management
Clinical CRF Review/Query Development and Resolution, Edits, and Statistical Analysis
Plans
· Coordinate and Perform GCP and GLP Audits. Preparation for BIMO Audits
· Quality Assurance Unit and consulting for GLP Non-Clinical Laboratory Studies
· Preparation of Investigator and FDA Meetings
· CRO Management
· Post Market Surveillance Studies
· Vendor Audits
· Development of Labeling, Advertising and Promotional Materials
How long in business? 12 years
PH: 714-328-9106
FX: 714-544-1716
EM: jlfralick@yahoo.com
Last updated: May 11, 2008
Back to List
Klassen Consulting, LLC
Dan Klassen, President
Drugs, Biologics/biotechnology
Project & Crisis Management
* Regulatory Affairs
* Regulatory Compliance
* Quality Assurance
Regulatory Consultation, Development & Technical Writing
* Chemistry, Manufacturing, and Controls/Quality Sections (CTD Module 3)
for IND, NDA, ANDA, BLA,
and Post-Approval Change supplements
* Regulatory and CMC related sections of Briefing Packages for FDA Meetings
* US Agent to Foreign API and Drug/Biologic/Biotech Product Manufacturers
Regulatory Compliance
* GMP Audits
* GLP Audits
* Regulatory Due Diligence Audits
* Regulatory Action Remediation
Training
* Good Manufacturing Practice (GMP) regulations
* Good Laboratory Practice (GLP) regulations
* Meetings with Regulatory Authorities
Regulatory Authority Inspections
How long in business? 2 years (consulting)
PH: 909-606-0543 ext 1
FX: 909-606-0548
EM: klassenconsulting@verizon.net
Last updated: February 17, 2009
Back to List
LMT Consulting LLC
Laurie M. Taddonio, President
Devices, Drugs, Biologics/Biotechnology
LMT Consulting specializes in assisting pharmaceutical and medical device companies
internationally with quality assurance and compliance. Services include, but are not limited
to, clinical quality systems assessments and consulting, SOP evaluations and writing, training,
mock FDA inspections, preparation for FDA inspections, assistance with FDA regulatory actions,
investigations of suspected fraud and scientific misconduct, and QA audits of sponsors, CROs,
clinical investigators, and IRBs. We work on projects ranging from simple audits to complex
criminal investigations. We proactively help companies to achieve successful outcomes in obtaining
product approvals as well as assist companies in response to FDA 483s, Warning Letters, Integrity
Holds, Application Integrity Policy (AIP), and Consent Decree.
LMT Consulting provides:
> Balance between your regulatory & business needs
> Effective & sustainable solutions
> Efficient, economical service
> Professional, high-quality products
Laurie has more than 20 years of experience in the FDA-regulated industry, including 10 years with the
FDA as a Bioresearch Monitoring Specialist Investigator, Bioresearch Monitoring Program Manager,
International Inspection Team member, and instructor and manager of FDA’s New Investigator and Analyst
Training. She was also a Regulatory Affairs Specialist and Manager before beginning her consulting
career in 2000.
How long in FDA-regulated industry? 20+ years
PH: 949-461-0527
FX: 949-461-0528
EM: LMTaddonio@aol.com
Last updated: February 17, 2009
Back to List
Medical-Device Consulting, Inc.
Louie Goryoka, President
Devices, Drugs, Biologics/Biotechnology
Our backgrounds are distinct, our clients are special, and our goals are simple:
Bring Your Products To Market by
committing our high confidentiality, high ethical
standards, high professionalism, and to be the contributor of a precise
and dependable
communication link between our client and regulatory agency.
Additionally provides personalized regulatory and quality assurance services that meet
your company needs including
U.S. Agent Representative and Official Correspondent.
These are samples of our services:
-
QSR, ISO 9000, ISO 13485, ISO 17025, ISO 14971 and MDD;
-
Implementation/Certification Regulatory Compliance/Audits-Internal and
Supplier Audits and Assessments;
-
QA/QC Compliance;
-
FDA Inspection Preparation;
-
Facility registration - Domestic and International;
-
Setup Domestic and International operational manufacturing and quality
assurance;
-
Device Submission 510(k)s, INDs, IDEs, PMAs;
-
Trouble Shooting: 483's, Warning Letters, Import Detentions;
and
-
Preparation of Technical File for product CE Mark
submission/registration.
How long in business? 22
years
PH: 818-735-0488
FX: 866-897-1713 (in the US) or 801-303-9004 (outside the US)
EM: mdci@m-dci.us
WS: www.m-dci.us
Last
update: May 12, 2008
Back to List
Med Exec International
Rosemarie Christopher, President
Devices, New Drugs/OTC, Generic Drugs, IVD,
Biologics/Biotechnology, Nutruitional Supp>
Med Exec International (MEI) serves the Pharmaceutical, Biotechnology, Medical Device,
Medical Diagnostics and Biologics industries in the placement of acknowledged achievers
within the Clinical Research, Medical Affairs, Regulatory Affairs, Quality and Engineering
Departments.
Founded in 1002, MEI focuses on both permanent and contract placement for high demand and
specialized positions. MEl's reputation and commitment to providing customized executive
search-and-placement in a rapidly growing competitive market have garjered the confidence and
endorsement of \Fortune 500, medium-sized and start-up firms locally, nationwide and throughout
the world.
How long providing this service? 17 years
PH: 818-247-1368
FX: 928-585-2036
EM: rosechristopher@medexecintl.com
WS: www.medexintl.com
Last update: May 25, 2009
Back to List
Medical Device Consultants, Inc.
William Morton, President
Medical Device Consultants, Inc. is a full-service CRO and regulatory consulting practice focused on
the needs of emerging and established medical device and diagnostic manufacturers. MDCI has helped
hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval,
and maintain compliance for products in the U.S. and internationally.
How long in business?: Since 1980
PH: 508-643-0434
FX: 508-643-2237
EM: info@mdci.com
WS: www.mdci.com
Last update: 07/08/06
Back to List
MediTech Strategic Consultants B.V.
Carla Kikken-Jussen, President & CEO / Diana Espinoza, RAC, VP, Business
Development (US-based)
Devices, IVD
MediTech Strategic Consultants B.V. (MediTech) is a European-based Full
Service CRO, specialized in and focused on medical devices and IVDs. MediTech
is based in The Netherlands next to the German and Belgium borders, with an
office based in San Francisco, CA. Our team consists of 23 employees and 11
Freelance Clinical Research Associates in Germany, Italy, France, Israel,
Poland, the Czech Republic, Sloviak Republic, the Ukraine, Hungary, and
Latvia. MediTech works closely with our clients, medical device and IVD
manufacturers, through the process of obtaining the CE Mark, to enable
commercialization of their medical products in the EU and to provide relevant
customized clinical, regulatory and quality consulting. As a critical element
to obtaining the CE Mark File (Technical File) often is clinical data,
MediTech supports clients in the setup and monitoring of clinical trials (as
needed), in accordance with GCPs and ISO 14155. All MediTech CRA’s are trained
accordingly.
Our services:
• Clinical Consulting Services and Monitoring
• Regulatory Assistance and Clinical Strategies
• CE Mark Guidance
• Authorized Representative Services
• Quality System Audits (according to U.S. regulations and ISO guidelines)
• Reimbursement Assessment
• Study Product Distribution and Traceability
• Data Management / Statistical Analysis
How long in business?: 20+ years of experience
PH: +31 (0) 43 306 33 20/+1 (415) 469-8401 (US)
FX: +31 (0) 43 306 33 38/+1 (415) 349-8402 (US)
EM: ckikken@meditech.nl / despinoza@meditech.nl
WS: http://www.meditech.nl
Last update: 05/30/09
Back to List
Merrill Brink International
Ron P. Tan, VP Language Solutions
Merrill Brink International is a leading provider of translation and localization services to the life sciences industry.
We are committed to quality and risk management, and are one of the few language providers in the world to be certified to
ISO 13485:2003 and ISO 9001:2000 and registered to ISO 14971:2007. Merrill Brink offers the following to reduce risk, increase
quality, as well as drive time and cost out of the translation process:
* Documented, internationally-recognized quality and risk management processes
* Content management system (CMS) support to streamline process development
* High-quality, documented method for qualifying and managing vendors and resources
* Web-based technology tools that increase employee productivity, drive down costs, decrease time to market, reduce document
review time, and increase consistency.
* Proven experience with international and business regulatory standards:
FDA regulatory programs
European Union Directives:
Medical Device Directive 93/42/EEC (MDD)
In Vitro Diagnostic Medical Device Directive 98/79/EEC (IVDD)
Active Implantable Medical Device Directive 90/385/EEC (AIMDD)
Directive 2004/27/EC concerning human medicines
ISO quality and risk management standards
Japanese Pharmaceutical Affairs Law (PAL)
CE Mark requirementsHow long in business?: 30+ years
PH: 562-496-1920
EM: ron.tan@merrillcorp.com
WS: http://www.merrillbrink.com
Last update: 05/8/09
Back to List
Noblitt & Rueland
Brent Noblitt, Senior Partner
Noblitt & Rueland, for over 20 years, has been a leading medical device
consulting and training firm specializing in technical FDA & international
regulatory issues. All of our staff members have considerable
specialized expertise and years working on medical device issues. Please
contact us for a quote or more information on any of our services.
Consulting Services (assistance & audits):
- Quality Systems & Audits (FDA & ISO 13485)
- Submissions (510(k)s, CE Marks & Technical Files/Dossiers, IDE, PMAs)
- Risk Management including ISO 14971
- Design Control
- Software Compliance & Development
- Software Verification & Validation
- Medical Device Safety IEC 60601 (2nd & 3rd Edition)
- Electronic Recordkeeping & Signatures (Part 11)
In-house Training Topics:
- Design Control, the FDA & ISO
- Risk Management, ISO 14971 and FDA Requirements
- FDA Quality System Regulation (QSR/GMP) & Inspections
- Auditing Quality Systems: for FDA & ISO Compliance
- Software, the FDA & ISO
- Software Verification & Validation Strategies
- FDA Electronic Recordkeeping & Signatures
- 510(k) Submissions: Getting to Market
- CE Marking Devices & IVDs
- IEC 60601-1: Medical Device Safety Requirements
- ISO 13485:2003 Implement & Maintain
- Strategic Sales & Marketing of Medical Devices in Europe
How long in this business? 20
years
PH: 714-258-4646
FX: 714-258-3990
EM: info@fdaconsulting.com
WS: http://www.fdaconsulting.com
Last update: May 1, 2008
Back to List
Pacific Bridge Medical
Ames Gross, President
Drugs, Biologics
Pacific Bridge Medical (PBM) is a leading independent consulting firm dedicated to assisting
medical companies in Asia. Our consultants have helped over 150 medical companies with business
development and regulatory issues since 1988.
We assist international companies in the following countries: China, Hong Kong, India, Indonesia,
Japan, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, and the United States.
PBM’s services include:
- Product registration and other regulatory matters
- Finding and qualifying distributors / agents to sell medical products
- Locating manufacturers and sourcing from Asian suppliers
- Quality control / Quality assurance
- Licensing technology / Setting up joint ventures
- Market research and competitive analysis
PBM publishes a FREE monthly Asian Medical eNewsletter which covers business development,
market trends, and regulatory issues in Asia. To subscribe, please see our website:
http://www.pacificbridgemedical.com or email us at
newssignup@pacificbridgemedical.com.
How long in this business? 17 years
PH: 301-469-3400
FX: 301-469-3409
EM: info@pacificbridgemedical.com
WS: http://www.pacificbridgemedical.com
Date Posted: October 14, 2005
Back to List
Promedica International
Ginger Clasby, Executive VP, Business Development
Devices, Drugs, IVDs, Biologics
Promedica International (PMI) is an ISO-certified contract research organization with
extensive experience in medical device studies. The company provides
the following services for FDA registration and post-market projects:
. Clinical study design, management, and monitoring
. Clinical data management and analysis
. Medical writing
. Clinical project auditing and training for GCP/ISO compliance
. Strategic marketing consulting
PMI's clients represent a variety of major medical specialties, which
include: anesthesiology/respiratory therapy, cardiovascular, cosmetic,
dental, general hospital/personal use, general/plastic surgery,
hematology/pathology, homeopathy, neurology, gastroenterology,
obstetrics/gynecology, oncology, ophthalmology/optometry, and orthopedics.
How long in business? 23 years
PH: 714-460-7363 x 25
FX: 714-460-7364
EM: gclasby@promedica-intl.com
WS: www.promedica-intl.com
Last update: May 5, 2008
Back to List
Quest International Consulting
Yasamin Ameri, Consultant
Drugs, Biologics/Biotechnology
Providing Quality Systems and Regulatory Affairs services for pharmaceuticals and biotech start-ups and
established companies; Designing and implementing QA and RA functions for start-ups and Gap analysis and
internal audits for established companies.
a) Quality Compliance
SOPs, Material Specifications
Batch production records
Quality manuals
Quality agreements with CROs and CMOs
Corrective Action plan and Preventive Action plan
Employee training on GMP/GLP/GCP/GDP requirements as well as how to receive and host a regulatory
authority inspection
Vendor and suppler audit
b) Regulatory compliance
CMC sections for their INDs, NDAs, and ANDAs
FDA meeting package
IND submissions
NDA submissions
ANDA submissions
Post-approval requirements
Preparing companies for Pre-approval Inspections
Help companies hosting FDA inspection
Preparing response letter for 483s and warning letters.
How long in business? 18 years
PH: 949-297-4445
FX:
EM: yameri@qiconsult.com
WS: http://www.qiconsult.com
Last update: February 2, 2009
Back to List
Quintiles Consulting
Drugs, Biologics/Biotechnology
Former FDA investigators, CDRH staff, and regional and district
directors join with former EU notified body staff and device industry veterans
to provide practical solutions.
Quintiles Consulting works with pharmaceutical, biotech and medical
device companies to maximize potential and minimize risk from discovery
through development and commercialization by providing expert strategic,
operational and technical advice. Building on the global reach and
expertise of Quintiles Transnational, Quintiles Consulting practice areas
include Product Development and Commercialization, Regulatory and
Quality, and Market Access. Quintiles Consulting have full-time consultants
based across the U.S. and Europe to serve its global clients. For more
information, please visit www.quintiles.com/consulting.
How long in business? 10 years
PH: 949-737-1505
FX: 949-737-1506
EM:
WS: http://www.quintiles.com
Last update: May 10, 2008
Back to List
Regulatory & Clinical Research Institute, Inc. (RCRI, Inc.)
Juli Denny, VP of Business Development
Devices, Drugs, IVD, Biologics/Biotechnology
RCRI is an experienced contract research organization (CRO) providing high quality expert consulting
services to medical device, IVD, and combination product industries. With their consultants averaging
18 years of relevant experience, they have the knowledge and expertise to assist your company in taking
products from concept to market.
RCRI's suite of services include:
• Regulatory Affairs
• Clinical Trial Design and Management
• Database Development & Compliance
• Quality Systems and Compliance
• Biostatistics
• Health Economics Outcomes Research
• Reimbursement
• Preclinical Services
• Venture Capital Due Diligence
As one of the few ISO 9001:2000 certified medical device CRO’s in the world, you can be confident in the
quality, reliability, and effectiveness of RCRI’s capabilities.
How long in business? 9 years
PH: 952-746-8080
FX: 952-884-6518
EM: jdenny@rcri-inc.com
WS: www.rcri-inc.com
Last update: June 6, 2008
Back to List
Regulatory Liaisons
Laura Guy, MS, RAC - Principal
Durgs, Biologics/Biotechnology
Regulatory Liaisons is a consulting organization that provides our clients with customized Regulatory Affairs
and Quality Systems services. We focus on working directly with our clients, to ensure we provide them with
the particular services they need at the time they need them. Working with you, we will formulate stratagems
to develop, conduct clinical trials, plan to market, and actually market your medical product—whether it be
regulated as a pharmaceutical, biologic, or medical device, including IVDs.
How long in business? 6 years
PH: 858-705-3838
EM: lauraguy@regulatoryliaisons.com
WS: http://regulatoryliaisons.com
Last update: May 10, 2008
Back to List
Resch Consulting
Gerda Resch
Services geared to small or start up organizations, which do not need full time regulatory
assistance. Provide guidance (FDA/EU), training (QSR/GMP/GCP etc.) and early submission
assistance (pre-IDE, IDE and CE marking).
How long in business? 1 year
PH: 661-993-8080
EM: resch@reschonline.com
Last update: May 8, 2008
Back to List
RxResearch Staffing
Rosemarie E. Christopher, President
Drugs, Biologics/Biotechnology
Built on a heritage of 20 years of regulatory, clinical research, medical affairs and quality
assurance recruitment, RxResearch Staffing provides optimum staffing solutions with 'subject expert'
contract professionals who deliver regulatory and clinical writing, GxPs auditing, clinical trial
monitoring, safety and risk management services.
How long in business? 3 years
PH: 818-552-2036
FX: 928-585-2036
EM: rchristopher@rxresearchstaffing.com
WS: http://www.rxresearchstaffing.com
Last update: May 2, 2008
Back to List
Scantron
Medical Device/Patient Tracking Services
Brian Hammill, Business Development Specialist
Devices,
Drugs, Biologics/Biotechnology
For medical device manufacturers that are required to track their devices, Scantron provides a
robust FDA compliant system for both device registrations and ongoing patient tracking initiatives.
This comprehensive, outsourced service solution has been delivered from and refined for the past 10 years.
For companies that have been struggling to maintain and effectively interface their patient registry with
functional departments, this is a proven alternative to developing or customizing your own internal application.
With a patient lost to follow up ratio of less than one percent, we offer a consistent, well defined and accurate
tracking process so that you can concentrate on the deliverables that built your business.
Services include:
* New registration document management & imaging
* Integrated source document imaging, indexing & conversion
* Ongoing patient tracking and investigation services
* Linking source documents to patient records
* QA/QC systems benchmarking and monitoring
* Integrated inbound/outbound call center
* Document generation engine for verification letters
* System business rule validation checks
* Documented quality compliance audits
* Interface options for secure client information access
* Out-of-Service device tracking
* Unregistered device tracking
* Following physician verification
* ID Cards and travel documents
How long in business? 10 years
PH: 651-683-6024
FX: 800-347-7226
EM: Brian_Hammill@Scantron.com
WS:
http://www.scantron.com/healthcare/medicaldevicetracking.aspx
Last update: May 12, 2009
Back to List
Strategic Regulatory Solutions
Gustavo Kobrin, Owner
Devices
Provides the following services:
Regulatory Affairs:
Domestic and international product registrations (IDE, PMAS, 510(k), CE, CMDR)
Product development support
Quality Assurance:
Quality System development
Internal and Supplier Audits
Product recall management
Interface with regulatory agencies Corrective action management (483, warning letter,
and other regulatory issues)
Gus Kobrin is a Notified Body auditor with 27 years of experience with medical device
quality assurance, regulatory compliance and regulatory affairs. References are
available
upon request.
How long in business? 8 years
PH: 714-508-8048
FX: 714-508-8048
EM: srsolut@aol.com
WEB: http://strategicregulatory.com
Last update: May 2, 20080
Back to List
Symbion Research International
Peggy Pence, PhD, RAC - CEO
Drugs, Biologics/Biotechnology
CRO Services (Drugs, biologics, devices/diagnostics):
Symbion is a full-service contract research organization (CRO), offering a complete
spectrum of strategic planning, product development, clinical research, and
regulatory services to U.S. and international clients.
Central Radiology Imaging:
Symbion offers unique, web-based solutions in Central Radiology Imaging through
ClinRad Services, its joint offering with a premier west coast radiology group.
Phase I/IIa Clinical Trials Unit:
Symbion supports Phase I/IIa clinical trials at a 24-bed clinical research unit in
Thousand Oaks, CA.
How long in business? 16 years
PH: 805-214-3714
FX: 805-214-3701
EM: ppence@symbionresearch.com
WEB: http://www.symbionresearch.com
Last update: June 6, 2008
Back to List
Validation Technologies, Inc.
George Sheaffer, VP Business Development
Devices, Drugs, Biologics/Biotechnology
Validation Technologies, Inc., an ISO 9001:2000 Certified Company, strives to maintain and inspire
professional excellence by providing Validation and Commissioning Services to the Pharmaceutical,
Biotechnology and Medical Device Industries. We have the experience, expertise, and commitment to provide
the superior service required to meet all of your validation and compliance needs.
We offer a full spectrum of services such as computer validation, cleaning validation, process validation,
clean room certification, temperature mapping, process equipment and facility qualification, and much more.
VTI offices are located in San Diego, Los Angeles, San Francisco, Scottsdale, Boston, Philadelphia, Toronto,
Puerto Rico, and China.
How long in business? 13 years
PH: 480-471-7486
FX: 480-471-7486
EM: gesheaffer@validation.org
WEB: http://www.validation.org
Last update: June 6, 2008
Back to List
|
