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Pre-Approval Inspection Experts

The following experts are available as pre-approval inspection consultants and pre-approval inspection expert witnesses.  Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Pre-Approval Inspection - The preapproval inspection determines compliance with current Good Manufacturing Practices (cGMPs) as well as a product specific evaluation concerning the manufacturing process of the application involved.

Synonyms:  PAI

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Join our distinguished experts for pre-approval inspection jobs, projects and consulting opportunities.


1 to 25
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Pre-Approval Inspection Experts
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Expert in Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, ... See full profile

Maharashtra, India

Expert in Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing the ... See full profile

Brussels, Belgium

Expert in Trandermal 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 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 Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. See full profile

California (CA), USA

Expert in All Aspects of Quality and Regulatory Support for FDA Regulated Drugs, Biologics and Devices
Advisor on technologies, production, regulatory affairs and quality compliance to senior management of companies producing biologics, medical devices, and pharmaceuticals, in the U.S., Germany, France, England, Sweden, Israel, Japan and China. See full profile

New York (NY), USA

Expert in Pharmaceutical/Biotech Clinical Trials, Regulatory, R&D, Mergers & Acquisitions, Trends, Outsourcing
Expert is Director of Regulatory Affairs and Clinical Trials managing $3.6 billion at at a pharmaceutical company in New York, NY. His expertise is in managing and deploying outsource/insource teams worldwide for multiple clinical trials and ... See full profile

Michigan (MI), 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 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 FDA Medical Device Quality Systems, Governmental Registration Process, International Business, GMP
As an ex-FDA official for over 21 years (not only as a experienced investigator/analyst, but also when he acted as field and HQ compliance officers during details to these offices), Expert is highly familiar with FDA compliance. He retains this knowledge ... See full profile

Indiana (IN), 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 GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
I am a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; I acquired more than 21 years' experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects ... See full profile

Québec, Canada

Expert in Steel wire manufacturing process
Expert has extensive experience in manufacture of wire such as cold heading wire, spring wire, rope wire, flat wire, shaped wire (both drawn and rolled), deformed wire, PC Strand, PC Wire, galvanized wire, low carbon bright wire, plating quality wire. See full profile

B.C., Canada

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 Pharmaceutical Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China
Expert has worked in the pharmaceutical industry as a research scientist, QC/QA director, vice president of product development, and has been involved in product development from pre-clinical through Phase 1 production. Expert has experience in setting up ... See full profile

Oklahoma (OK), USA

Expert in QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. See full profile

California (CA), USA

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 Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles to the ... See full profile

Germany

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 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 Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological ... See full profile

New Jersey (NJ), USA

Expert in Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a PhD in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and ... See full profile

New Jersey (NJ), 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 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

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