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Drug Experts

The following experts are available as drug consultants and drug expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Drug - A substance, such as a pharmaceutical product, used in or on the surface of the body to diagnose, cure, mitigate, treat, or prevent disease, or to otherwise affect the structure or function of the body.

Synonyms:  drug product, medication, medicine, therapeutic drug, therapeutic pharmaceutical

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Expert in Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer's and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic's regulations. See full profile

Quebec, Canada

Expert in Pharmaceutical Development, strategy planning and execution
Expert graduated in Biology at the University of Utrecht, The Netherlands, in 1984. From 1985-89 he was a PhD student at the University of Basel. The research in the field of gene regulation was carried out at the Friedrich Miescher Institute (FMI; ... See full profile

Switzerland

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 Medicine, Pharmacy, Pharmacology/Toxicology with Emphasis on Cannabanoids and Opioids
Expert is a practicing physician and pharmacist, who also holds a Master's of Science degree in Pharmacology and Toxicology. He has performed research in the field of Pharmacology with particular focus on drugs of abuse, cannabinoids and opioids. See full profile

Virginia (VA), USA

Expert in Pharmaceutical Product Development and Good Manufacturing Practices (cGMP, IQ/OQ, CMC, FDA, etc.)
Expert is a consultant to the pharmaceutical and allied industries. His background includes 28 years with DuPont and DuPont Merck in a variety of positions. In his last assignment at DuPont Merck, he was Senior Director of Technology and Engineering in ... See full profile

New Mexico (NM), USA

Expert in Pharma/Biotech Development, Life-Cycle Management, 505(b)(2), Chemical Development, CRO Services
Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. See full profile

Illinois (IL), 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

Expert in Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation ... See full profile

New Jersey (NJ), 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 Pharmaceutical Development, cGMP, Formulation, Analytical Development, Poorly Soluble compounds
Expert is an expert in pharmaceutical development. He has 20+ years experience solving commercially relevant problems in the pharmaceutical industry. He has extensive experience managing multi-disciplinary drug delivery projects from inception to completion, ... See full profile

Oregon (OR), USA

Expert in Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due ... See full profile

Virginia (VA), USA

Expert in FDA Compliance, Pharmaceutical New Products, Management Training, Seminars, Inspections, Audits
During his employment with the Food and Drug Administration, Expert received five grade promotions, with his last position being that of Director of the Science Branch of the Philadelphia District. Expert's area of responsibility included all the ... See full profile

Georgia (GA), USA

Expert in Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and ... See full profile

Illinois (IL), USA

Expert in Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design, ... See full profile

Massachusetts (MA), USA

Expert in Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training ... See full profile

Alabama (AL), USA

Expert in Psychopharmacology in Historical Perspective, Regulatory Behavior, etc.
Over the past 20 years he has done extensive research on the history of drug discovery, drug development, drug registration, and the use of psychopharmaceuticals in medical practice. Among the documents he has collected are the virtually complete set of ... See full profile

Wisconsin (WI), USA

Expert in Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in ... See full profile

Pennsylvania (PA), USA

Expert in Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument ... See full profile

Massachusetts (MA), 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

Netherlands

Expert in Pharmaceuticals, Drug Delivery, OTC, and Rx products
Expert actively consults in nearly all routes of drug delivery, including oral, transdermal, topical, inhalation, injection/infusion, nasal, buccal and others. He holds a Ph.D in Polymer Science and Engineering, as well as an MS on the same topic. See full profile

Pennsylvania (PA), USA

Expert in Chemistry R&D and cGMP Manufacturing, Pharmaceutical Development
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of ... See full profile

Massachusetts (MA), USA

Expert in Formulation, Development and Manufacturing of Pharmaceutical Dosage Forms
Expert has extensive product development experience in solid dosage forms (TABLETS {IR & ER} , HARD & SOFT GELATIN CAPSULES AND POWDERS); Liquid dosage forms ( SOLUTIONS, SUSPENSIONS & EMULSIONS) from conception through to stability trail, clinical ... See full profile

NSW, Australia

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 Europe Drug Market, Drug Reimbursement, Drug Therapy, Generic Drug Market, Biologic Therapy, HIV
Expert Borrás Blasco is an hospital pharmacy specialist, with a PhD and Masters in Pharmaceutical Care and Pharmacy Oncology Diplomade from Valencia University, Spain, as well as a Masters in Pharmacovigilance from Sevilla University, Spain. See full profile

Valencia, Spain

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