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drug

product

Food and Drug Administration new drug code

Food and Drug Administration drug registration

Food and Drug Administration drug packaging regulation

Food and Drug Administration National Drug Code

drug-drug interaction

over-the-counter drug regulation

antitumor drug

Food and Drug Administration laser safety regulation

drug delivery

transdermal drug delivery

drug allergy

controlled-release drug delivery

illegal drug

Department of Transportation drug testing regulation

antiarthritis drug

intravenous drug delivery

Drug Enforcement Agency-restricted chemical

drug development

over-the-counter drug

in vitro diagnostics Food and Drug Administration code

computer-aided drug design

over-the-counter drug packaging

antimycotic drug

drug contamination

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 Pharmaceuticals, Clinical Pharmacology, Toxicology, Drug Development, Regulatory Affairs, Patents
Expert worked in pharmacological research concerning opiate analgesics. The objective of the research was to find an anti-diarrheal drug with minimum analgesic actions. In particular, he led the research team that discovered and developed nufenoxole, ... See full profile

Illinois (IL), 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 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 and Drug Safety in New Drug Development and Marketing/Commercialization
Expert has a working knowledge of ICH guidance related to patient protection and relevant US laws. 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 ... See full profile

New Jersey (NJ), 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 Health and Personal Product Development
Expert brings 40 years of experience directing the development and evaluation of new and improved pharmaceutical and personal care products to assist you in managing the technical aspects of your business. In addition to developing several ... See full profile

New Jersey (NJ), 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. 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 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 Pharmacy Practice, Pharmacy Standard of Care, Pharmacology, Drug effects, Drug Misadventures, FDA
He has held membership in various professional organizations, and has served as an officer as well as in other capacities within these organizations. He has also served in an administrative, clinical, advisory, or committee-related capacity for a host of ... See full profile

West Virginia (WV), USA

Expert in OTC, Generic, and New Drugs, Medical Device Regulations
Expert now consults clients on matters pertaining to OTC drugs, generic drugs, new drugs and devices regulations and performs inspections of manufacturing facilities for compliance with current Good Manufacturing Practice Regulations. See full profile

Virginia (VA), 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 Europe Drug Market, Drug Reimbursement, Drug Therapy, Generic Drug Market, Biologic Therapy, HIV
Expert is an expert in EMEA drug regulation at it applies to marketed drugs. Drug regulation, he has knowledge in the steps that need to be met during pre-clinical and clinical drug development of drug candidates. He has expertise on the EMEA, ... See full profile

Valencia, Spain

Expert in Pharmaceutical Drug Development, Strategic Executive Management, Biopharma Mergers and Acquisitions
Expert has over 20 years of experience. He is extensively active and has significant experience and expertise in Europe and the US in the areas of drug development and financing throughout Europe and the US. He was responsible for the overall ... See full profile

Netherlands

Expert in Controlled-Release Drugs
Solid pharmaceutical product; tablet coating; drug dosage form development. Expert has served as Director of Product Development at the leading firm involved in the discovery and application of pharmaceutical coating products and technology. See full profile

Pennsylvania (PA), USA