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Regulatory Affairs Experts

The following experts are available as regulatory affairs consultants and regulatory affairs expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Regulatory Affairs - The department that is responsible for compliance with government regulations and liaisons with regulatory agencies.

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Regulatory Affairs Experts
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Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, ... See full profile

California (CA), USA

Expert in Drug Regulatory Affairs (European Union)
Expert has nearly 20 years experience in Drug Regulatory Affairs (RA). Before setting up his own RA consultancy in June 2008, he has worked in various senior RA positions in the pharma and biotech industrie having been located in Germany, the UK, ... See full profile


Expert in Quality Assurance, Regulatory Affairs, and New Product Development Consultant
Bs Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. See full profile

Illinois (IL), USA

Expert in Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods
Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Expert's Firm. See full profile

Illinois (IL), USA

Expert in Oil, Liquids and Natural Gas Pipeline Tolls, Tariffs, Cost of Service Models
Expert, a professional engineer, has been involved in the oil and natural gas industry for over 35 years in Canada and the United States. For half his career he has been involved in the energy consulting sector. He specializes in the areas of: * ... See full profile

Alberta, Canada

Expert in Clinical Development, Orphan Drugs, Regulatory Development
Following more than 25 years in the pharmaceutical industry (Big Pharma, Contract Research Organizations, Small Pharma), Expert has accumulated experience from several hundred clinical studies, primarily in Phase I/Phase II ("First-in-Human", ... See full profile

Siena, Italy

Expert in Real Estate Land Development, Entitlements, Feasibility Analysis, Zoning, Planning, Land Use
Expert graduated from Dickinson College (B.A. with double major in Economics and Political Science; 1976) and Georgetown University Law School (J.D.; 1979). He has spent the last 25 years of his career both owning and operating real ... See full profile

New Jersey (NJ), USA

Expert in Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems ... See full profile

California (CA), USA

Expert in FDA Regulatory Consultant for Medical Devices, Cosmetics, and OTC Drugs
Expert is a renowned authority in the cosmetic, OTC drug and medical device industries. He has had over 40 years of experience dealing with regulatory, scientific, and technical issues for FDA regulated industries. He served as Senior Vice ... See full profile

Maryland (MD), USA

Expert in Clinical Pharmacology, Toxicology, Drug Development, Product Liability, Regulatory Affairs, Pharmaceutical Patents
Expert worked in pharmacological research concerning opiate analgesics. The objective of the research was to find an anti-diarrheal drug with minimal analgesic and addiction potential. In particular, he led the research team that discovered and ... See full profile

Illinois (IL), USA

Expert in Anesthesiology, Pain Medicine (Chronic/Acute), Perioperative Medicine, Clinical Research, Regulatory
Analgesia - Expert has extensive experience in analgesic research, drug development, regulatory affairs (including REMS) and marketing. He is an author for various publications, and presentations on different classes of analgesics. See full profile

Florida (FL), USA

Expert in Metal Finishing
Expert has 30 years of practical experience in metal finishing. He specializes in plating (electroplating, electroless plating), anodizing, degreasing, phosphating, decorative coatings, and using unique coatings for a wide ... See full profile

Illinois (IL), USA

Expert in FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media
Expert currently serves as Regulatory Counsel for Allergan, providing proactive legal support to senior management, product brand teams, and client groups across organization, advising and educating on regulations pertaining to pharmaceutical products. See full profile

New Jersey (NJ), USA

Expert in Regulated and Hazardous Materials Auditing, Compliance, Programs, Processes and Training
Expert has utilized his scientific and logistics experience to analyze and consult regarding materials that were thought to be difficult or "impossible" to produce or ship in normal modes commerce. With an intimate knowledge of material and production ... See full profile

South Carolina (SC), USA

Expert in Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. See full profile

Arizona (AZ), USA

Expert in FDA Regulatory Affairs, Compliance and Submissions
Expert is a former FDA reviewer with two decades of industry consulting experience in the following areas: GCP/TMF auditing, SOP writing, regulatory affairs, clinical development, submission preparation for drugs and devices, SAS programming, Part 11 ... See full profile

Maryland (MD), USA

Expert in Medical Device Product Commercialization from R&D to Manufacturing, Regulatory and Clinical Trials
Expert is a medical device consultant and executive with more than 20 years experience in the medical device industry. His expertise spans all aspects of medical device commercialization, from medical device product development to medical device ... See full profile

California (CA), USA

Expert in Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. See full profile


Expert in Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). See full profile

Minnesota (MN), USA

Expert in FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and ... See full profile

California (CA), USA

Expert in Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, ... See full profile

Maharashtra, India

Expert in Regulatory Affairs for Cosmetics, Fragrance, Health Products, Good Manufacturing Practices
Expert has been nominated in 2009 as a National Court Expert in Paris (Chemicals Cosmetics Perfumes and Cosmetic Good Manufacturing Practices) He became licensed as well in 2009 on toxicological and safety evaluation for cosmetic products ... See full profile


Expert in Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst, an editor ... See full profile

Virginia (VA), USA

Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile

Oklahoma (OK), USA

Expert in Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. See full profile

Florida (FL), USA

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