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bioequivalence

  

material property

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animal drug testing

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drug bioavailability

 

Bioequivalence Experts

The following experts are available as bioequivalence consultants and bioequivalence expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Bioequivalence - A property of drugs signifying that one drug has the same strength and similar drug bioavailability as does another drug in the identical dosage form.

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1 to 11
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Bioequivalence Experts
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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 Dermal Drug Delivery
Dermal absorption; skin absorption; membrane permeation (especially skin). Expert has focused his laboratory work for over 20 years on the above topics, during which time he has written over 100 publications. His studies have included ... See full profile

Michigan (MI), USA

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 Pharmaceuticals, Biotechnology, Clinical Pharmacology, Pharmacokinetics, Clinical Trials
Expert is an expert in drug discovery and development years of experience in clinical pharmacology, pharmacokinetics and clinical trials of pharmaceuticals. Trained in medicinal chemistry, Expert undertook clinical pharmacology research in a ... See full profile

Victoria, Australia

Expert in Veterinary Medicine: Comparative Medicine, Clinical Trials, Licensing and Business Development
Expert has over 15 years in animal drug trials including lab animal pre-clinical studies to field safety and efficacy studies in companion animals. Expert is experienced in drug, biologic, nutraceutical, diagnostic and medical device testing for ... See full profile

Arizona (AZ), 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 PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all ... See full profile

North Carolina (NC), USA

Expert in Psychopharmacology, Drug Development, Medical Devices
Expert's training in psychiatry has focused on biological psychiatry (the biological basis of psychopathology) and on psychopharmacology. He currently directs the Developmental Biopsychiatry Research Program and the Laboratory of Developmental ... See full profile

Massachusetts (MA), USA

Expert in Production and Design of Pharmaceutical Products
Expert Nowaday is working as R&D and QC manager in a pesticides and biopesticides industry. He has 11 years of experience on development and transfer of new pharmaceutical products from R&D into manufacturing. He developed pharmaceutical products as ... See full profile

Mexico City, Mexico

Expert in Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials ... See full profile

California (CA), 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

 
 

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