EXPERT NUMBER: 3278. STATE: NJ. REGION: Eastern, Northeast. COUNTRY: United States Expert Witnesses.
Provides Opinion & Testimony In:
Pharmaceutical Development, Pharmaceutical Scale Up, Instrumentation, Manufacturing, Drug Development, Drug Safety, FDA Medical Device Regulation, 21 CFR Part 11, FDA New Drug Review Approval Procedures, Standard Operating Procedures, FDA Regulation Compliance, Product Process Optimization, Science, Statistics, Pharmaceuticals Regulatory Affairs, Quality Assurance, GXP, GMP, GLP, GCP Compliance, Regulatory Issues, Risk Management, Review FDA Correspondence,
EXPERT NUMBER: 3571. STATE: FL. REGION: Eastern, Southeast, Southern. COUNTRY: United States Expert Witnesses.
Provides Opinion & Testimony In:
Regulatory Affairs, Clinical Affairs, Quality Assurance, Regulatory Compliance, Medical Device, Combination Product, Design Dossier, Medicinal Dossier, Director, Client Manager, Project Manager, 510(k),515i, Pre-IND, IND, Pre-IDE, IDE, HUD, USAN, HDE, PMA, Pre-Sub, Recall, Correction, CTA, FDA, CDRH, CE, OUS, MAF, Pre-submission, Pre-IDE, De Novo, Recall Correction, Appeal, Supplement, Annual report, FSN, FMEA, CER, FSCA, MDEL, MDR, 13485, 10993, 14971, 60601, CMDR, PMS, PMCF, NCA, EFTA, Apostille, legalization, CFG, CFS, QMS, QC, 21 CFR 820, 21 CFR 801, 21 CFR 803, MDL, 21 CFR 807, MEDDEV, NB, Product Liability, Infringement, Patent Infringement, Injury law,CE, TUV, Intertek, SGS, DGM, NSAI, SNCH, BSI, UL, Medicinal Consultations, MHRA, MPA, ETAT, License Applications, Health Canada, TGA, Covid-19, EUA
EXPERT NUMBER: 3033. STATE: MD. REGION: Eastern, Northeast. COUNTRY: United States Expert Witnesses.
Provides Opinion & Testimony In:
Pharmaceutical, New Drug Application Under FDA, Medical Imaging, Oncology, Pain Management, Anti Infectives, Ophthalmics, Drug Development, Drug Identification, Drug Labeling, Drug Labels, Drug Warnings, Drug Safety, FDA Medical Device Regulation, FDA New Drug Review Approval Procedures, Medical Devices, Pharmaceutical Development, Pharmaceutical Process Chemistry, Pharmaceutical Science, Pharmaceuticals, Pharmaceuticals Manufacturing, Pharmaceuticals Regulatory Affairs, Quality Assurance, GXP, GMP, GLP, GCP Compliance, Regulatory Issues, Risk Management, Review FDA Correspondence,
EXPERT NUMBER: 2806. STATE: VA. REGION: Eastern, Southeast, Southern, TN&Contiguous. COUNTRY: United States Expert Witnesses.
Provides Opinion & Testimony In:
General Industrial Hygiene Safety Issues Warning Labels, industrial hygiene, Health & Safety Standards, OSHA MSHA EPA Regulations Practices, Asbestos General Toxic Torts Litigation Support, Hazardous Exposure Risk Assessment Modeling, Health & Safety Programs, MSDS Warning Labeling, General Forensic Science Litigation Support, Personal Injury Product Liability Litigation Support, Environmental Microbiology,
EXPERT NUMBER: 2867. STATE: MI. REGION: Central, Eastern, Midwest, Northeast, Southeast, Southern. COUNTRY: United States Expert Witnesses.
Provides Opinion & Testimony In:
Regulatory Affairs, FDA Regulations, Quality Systems, Drug Formulation, Quality Management, Dietary Supplement, Medical Device, User Requirements Specification, Design Development Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, Pharmaceutical, Validation, Compliance, CAPA, Corrective Preventive Action, Root Cause Analysis, Risk Assessment, Failure Mode Effects Analysis, Fault Tree Analysis, HAZOP, Hazard Analysis Critical Control Points, R&D, New Product Development, Calibration, Installation Qualification, Operation Qualification, Performance Qualification, Process Validation, Process Design, Process Performance Qualification, Continuous Process Verification, Statistical Process Control, Stability, Change Control
