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abbreviated new drug application

  

application

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investigational drug procedures

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generic drug manufacturing

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generic drug

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drug validation

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computer-aided new drug application

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Food and Drug Administration drug registration

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Food and Drug Administration

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new drug

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Food and Drug Administration new drug code

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new drug application

 

Abbreviated New Drug Application Experts

The following experts are available as abbreviated new drug application consultants and abbreviated new drug application expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Abbreviated New Drug Application - An application for a license to market a generic (or a duplicate) version of a drug that has already been granted an approval under a full NDA

Synonyms:  ANDA

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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 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 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 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

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 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 Rx Marketing, Rx Benefits, Specialty Pharmacy, Rx Benefits Management, Evidence-Based Rx Use
Since 1989, Expert has provided consulting related to pharmacy benefits, marketing of pharmaceuticals, biotechnology and biological products, pharmaceuticals- related business strategy and new business development. See full profile

California (CA), USA

Expert in Licensing, Biopharma, Pharma, Medical Devices, Chemistry, Agreements, Business Development
Expert has more than 25 years of expertise in transactional and regulatory counseling, acquisition, licensing, due diligence, dispute resolution, opinions, and appeals for the development and commercialization of health care, pharmaceutical, biotechnology, ... See full profile

Colorado (CO), USA

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 Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition of ... See full profile

New Jersey (NJ), USA

Expert in Quality Assurance, Regulatory Affairs, Marketing and Business Strategy for Life Sciences Industry
He has performed compliance audits to 21 CFR Part 11. He has developed qualification protocols to test systems compliant with 21 CFR Part 11. He has developed advertising campaigns, written copy for advertisements and managed the creative development of ... See full profile

Montana (MT), 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, CMC, Project Management, Intellectual Property
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, ... See full profile

Kent, United Kingdom

Expert in FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action in a ... See full profile

Michigan (MI), 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 Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP's/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international ... See full profile

India

Expert in Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product ... See full profile

Florida (FL), USA

Expert in Pharmaceutical Research and Product Development, Formulation and Analysis
Expert has spent nearly 25 years at Expert's Consulting Firm, teaching undergraduate and graduate courses in controlled drug delivery systems, pharmaceutical solutions, drug stability, drug diffusion and pharmaceutical rate processes. See full profile

Pennsylvania (PA), 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 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 Pharmaceutical Chemical Process R&D, Manufacturing, Disaster Recovery, Software Design
As the IT Manager for a major pharmaceutical company Expert has expertise in selection and validation of document management systems, inventory control, instrument calibration systems, as well as computer software utilized in the pharmaceutical ... See full profile

New York (NY), USA

Expert in Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new ... See full profile

Florida (FL), USA

Expert in Medicine, Especially Pathology (Laboratory Medicine), Women's Health, Cervical Cancer, Breast Cancer
Expert has practiced diagnostic surgical pathology for over 20 years, with special interest and experience in gynecologic and gastro-intestinal pathology. She has participated in several clinical trials with pharmaceutical clients in these areas, and has ... See full profile

New York (NY), USA

Expert in Business Development and Licensing, Life Sciences
He has broad expertise in the life science industry, ranging from technical and business development of biological and conventional drugs, diagnostics and human nutrition. Expertise involves the use of conventional and molecular diagnostics in disease ... See full profile

Pennsylvania (PA), USA

 
 

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