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New Drug Experts

The following experts are available as new drug consultants and new drug expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  New Drug - A drug that is not generally recognized among appropriate experts as safe and effective for use under the prescribed, recommended, or suggested conditions of use; it includes a drug that has not been used extensively or for a substantial period of time under such conditions.

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Join our distinguished experts for new drug jobs, projects and consulting opportunities.


1 to 25
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New Drug Experts
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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 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 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 New Drug Development and Approval
Expert has extensive experience in complying with requirements of that part of the Act pertaining to drugs as implemented by the regulations of the FDA The requirements affect the development of drugs from the initial stages of screening to ... See full profile

Arizona (AZ), USA

Expert in Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section of these summaries under the ... See full profile

India

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 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 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 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 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 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 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 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 Formulation, Drug Delivery, CMC, NDA, and Formulation Patents
Expert has developed multiple immediate release and modified release oral formulations at ALZA Corporation and at Transcept Pharmaceuticals. Many of these formulations have been commercialized including Invega (OROS paliperidone) and Exalgo (OROS ... See full profile

California (CA), USA

Expert in Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many ... See full profile

New Jersey (NJ), USA

Expert in Neuropharmacology, Aging, Brain Injury, Memory Impairments, Imaging, Neurodegenerative Disorders
Expert has worked on several projects involving Alzheimer's disease (AD). In particular, he has used genetically engineered mouse models to test ideas and answer questions related to how biological memory might be affected by AD pathophysiology. See full profile

Manitoba, Canada

Expert in Pharmaceutical & Life Science Research and Manufacturing, New Drug Discovery, Therapeutic Strategy
By using standard analytical tools of cellular and molecular biology he has elucidated the molecular mode of action of an anti-diabetic candidate BMOV on the key components of insulin signaling cascades like IR Kinase (IRK) and IRS complexes including ... See full profile

Gyeonggi-do, Korea (South)

Expert in Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science ... See full profile

Florida (FL), USA

Expert in Drug Delivery, Formulation Development of NCE's, Preformulation, Stability, Clinical Manufacturing
She has been involved in contract manufacturing of pharmaceuticals for the drugs and devices. Contract manufacturing for drugs have included identification, evaluation, screening and selection of CRO's and CMO's in the area of sterile solution and oral ... See full profile

California (CA), USA

Expert in Pharmaceutical Marketing; P&L Management; Reimbursement Strategy
Expert is the Brand Director at Expert's Firm, since April 2009. He is currently responsible for all aspects of marketing one of the most complex, heavily contracted brands in industry including full P&L, brand strategy and life cycle management. See full profile

New Jersey (NJ), 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 Pharmaceutical Development
Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President ... See full profile

Florida (FL), USA

Expert in Biotechnology, Pharmaceutical, Diagnostic and Medical Device Development and Licensing
Expert has been involved with biotech and pharmaceutical drug development for over 12 years. She has worked as protocol physician or development team leader in inflammatory bowel disease, osteoporosis, sexual dysfunction and gout. See full profile

Ohio (OH), USA

Expert in Antimicrobial Screening, Drug Discovery, Clinical Microbiology, Fermentation Technology
Expert has over ten years of experience in drug discovery with emphasis on screening bioactive natural compounds possessing antimicrobial, antioxidant, anticancer and wound healing activities of plant (Ethnopharmacology / Pharmacognosy) as well ... See full profile

Punjab, India

Expert in Pharmaceutical Technology, Scale-up, Wet granulation end-point, Tableting, Compaction
Expert has 25 years experience in pharmaceutical process scale-up, wet granulation end-point determination, compaction and tableting. He has published many articles on these topics, edited "Pharmaceutical Process Scale-up" handbook, and wrote chapters in ... See full profile

New Jersey (NJ), USA

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