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Expert in Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine
Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, ... See full profile

Michigan (MI), 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 Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into ... See full profile

Delaware (DE), USA

Expert in orthopedic R&D, regulated (GLP) nonclinical trials, large animal models, surgery, vet med
Expert is the Director of the Comparative Orthopaedic Research Laboratory in the Department of Clinical Studies at the University Of Pennsylvania School Of Veterinary Medicine. Expert trained in both human and veterinary medicine, and ... See full profile

Pennsylvania (PA), USA

Expert in Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. See full profile

California (CA), 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

Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, ... See full profile

California (CA), 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 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 Biomaterials: Biocompatibility, Pathology, Devices
Expert is a D.V.M. with a Ph.D. in veterinary pathology. He is also board certified by the American College of Veterinary Pathologists. As part of his Ph.D. research training he was involved in the characterization of several spontaneous large ... See full profile

North Carolina (NC), USA

Expert in Analytical Chemistry: HPLC, LC-MS, Bioanalysis. R&D projectmanagement; writing of publications
Expert's scientific expertise includes the development, optimization and validation of quantitative bioanalytical methods for small molecules, peptides and biopharmaceutical drugs as well as for their metabolites in biological fluids (plasma, urine, ... See full profile


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 Heavy Chemicals, Plastics, Wasteless Processing
With 32 years of experience in handling and managing Chemical plants in many countries, mastered and proved to the accreditation of achievements in Concept Identification, Design, Manufacturing, Quality Control, Inventory Mgt., Indigenization, Market ... See full profile

Secunderabad, India

Expert in Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare ... See full profile

Illinois (IL), 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 Endocrinology, Human Physiology, Heart Disease, Diabetes, Obesity, and Clinical Trials
Expert is clinically trained as an Endocrinologist, and performs research in human physiology and clinical trials. The basis of his work is in moving discoveries from the concept stage into human testing, often undertaking first-in-human studies or ... See full profile


Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He 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 Genomics and Biomarkers
Expert is a solutions-oriented business development and scientific professional with broad experience in the development of genomics and proteomics tools and the applications of these tools in research and drug discovery. See full profile

Connecticut (CT), USA

Expert in Genetics, Transgenic, Epigenetics, Nutrition, Vascular, Cell Biology, Atheroclerosis, Angiogenesis
Expert has been trained in biochemistry and microbiology at the Technical University of Munich, Germany and he holds degrees equivalent to an MSc in Biology and Biotechnology. He has a Ph.D. from the University of Munich in Genetics. See full profile

United Kingdom

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 Diabetes, Incretin Therapy, Lipid Disorders, Depression, Bipolar Disorder, Fibromyalgia
Expert has extensive experience in using all psychotropic medications for treatment of depression, anxiety, bipolar disorder, eating disorders and schizophrenia spanning 26 years of residency and private practice. He has worked in locked psychiatric ... See full profile

California (CA), 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


Expert in Parasitology, Immunology, Agricultural Systems
He has many years research experience in understanding and mitigating the impact of a range of agricultural pests such as parasitic worms and ticks. He has carried out numerous small and large animal drug efficacy and residue trials which have either been ... See full profile

New Zealand

Expert in Transplant and Cell Therapy for Diabetes
Expert has been specialized in clinical diabetes since 1987.Initally, he was involved in metabolic studies dealing with insulin action and secretion and factors of insulin resistance. Later on, he was involved in many investigator driven studies aiming ... See full profile

Czech Republic

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


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