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displays information about consultants who provide regulatory, clinical, and quality system services in Orange County and elsewhere. To
post consultant services information go to the Consultant Services Form page and follow the instructions provided there.
Caution: OCRA lists names of individuals and organizations offering the consulting services described on this page without pre-screening or endorsement. Anyone availing themselves of these services does so at their own risk and retains sole responsibility for determining and insuring the appropriateness of those
services to their needs while holding OCRA harmless and without liability for any negative consequences arising from that use.
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Biologics Consulting Group, Inc.
Ruth Wager, Ph.D., 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
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
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
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.
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
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.
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.
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
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
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
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
Med Exec International
Rosemarie Christopher, President
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 1992, MEI focuses on both permanent and contract placement for high demand and specialized
positions.
MEI’s reputation and commitment to providing customized executive search-and-placement in a rapidly
growing competitive market have garnered the confidence and endorsement of Fortune 500, medium-sized and
start-up firms both nation wide and throughout the world.
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.
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
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
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.
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.
Quintiles Consulting
Elaine Messa, Vice President
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.
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.
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).
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.
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.
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.
Orange County Regulatory Affairs Discussion Group Kimberly Syre
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-387-9047
Email: ksyre@cox.net
