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Expert in Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. See full profile

Arizona (AZ), 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 Regulated and Hazardous Materials Auditing, Compliance, Programs, Processes and Training
Expert has utilized his scientific and logistics experience to analyze and consult regarding materials that were thought to be difficult or "impossible" to produce or ship in normal modes commerce. With an intimate knowledge of material and production ... See full profile

South Carolina (SC), USA

Expert in FDA Regulatory Consultant for Medical Devices, Cosmetics, and OTC Drugs
Expert is a renowned authority in the cosmetic, OTC drug and medical device industries. He has had over 40 years of experience dealing with regulatory, scientific, and technical issues for FDA regulated industries. He served as Senior Vice ... See full profile

Maryland (MD), USA

Expert in Environmental Management
A significant portion of Expert's expertise is involved with assisting industrial manufacturing companies with determining their air emission sources, their facility's emissions, and Potential to Emit. This includes evaluation of whether the ... See full profile

Pennsylvania (PA), USA

Expert in Environmental Services, Regulatory Compliance, Waste Transportation & Disposal, Landfills
20+ Years Environmental Management Experience / Leader in Business Strategy & Acquisition / Western US Facilities Oversight / Training & Regulatory Compliance / Human Resource Management & Professional Growth Expert is a results-driven business professional ... See full profile

Arizona (AZ), USA

Expert in Real Estate Land Development, Entitlements, Feasibility Analysis, Zoning, Planning, Land Use
Expert graduated from Dickinson College (B.A. with double major in Economics and Political Science; 1976) and Georgetown University Law School (J.D.; 1979). He has spent the last 25 years of his career both owning and operating real ... See full profile

New Jersey (NJ), USA

Expert in Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due ... See full profile

Virginia (VA), USA

Expert in Wastewater & Permits, Electro/Electroless/Semiconductor Plating Processes, Water Recycle
Expert has 25 years of R&D, technical service, and consulting experience in most areas of electroless plating, electrolytic plating, and printed circuit board plating. He owns his own consulting and contract R&D firm, which has ... See full profile

California (CA), USA

Expert in Oil & Gas, Environmental Law, Regulation, Petroleum Geology & Mineral Leasing
As a practicing environmental attorney for 10 years (1995-2005), he represented several clients in matters involving air quality compliance and alleged environmental effects due to air pollution. He reviewed several air pollutant effect studies and ... See full profile

Texas (TX), USA

Expert in Biomedical Engineering, Biomechanics, Industrial Hygiene, Toxicology, Epidemiology, Occupational Health
Expert is a physician, attorney, industrial hygienist, and biomedical engineer licensed to practice medicine and law in Michigan and Illinois. He is a graduate of Kalamazoo College, Wayne State University School of Medicine and Law School as ... See full profile

Illinois (IL), USA

Expert in Waste Management, Waste Treatment, Incineration, Air Pollution Control, Combustion, Environmental
Expert has more than 40 years of comprehensive consulting & engineering & experience with specialized expertise in air pollution control (APC) systems & equipment; solid, medical & hazardous waste management, treatment, disposal & incineration; ... See full profile

New York (NY), USA

Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile

Oklahoma (OK), 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 Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination ... See full profile

Minnesota (MN), USA

Expert in FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media
Expert currently serves as Regulatory Counsel for Allergan, providing proactive legal support to senior management, product brand teams, and client groups across organization, advising and educating on regulations pertaining to pharmaceutical products. See full profile

New Jersey (NJ), USA

Expert in EPA & CARB Mobile Emissions Regulations for Fleet Compliance, BACT Certification and Verification
Expert's Firm provides emissions consulting and testing services related to EPA, California Air Resources Board and State Agency emissions regulations. We have helped fleet owners, emerging technologies and Fortune 500 companies with a wide range of ... See full profile

California (CA), USA

Expert in Chemical Regulations and Safety
Toxic substance control act (tsca) regulations. Expert has extensive experience in helping clients comply with regulations under TSCA since initial promulgation in 1977. His current consulting service organization emphasizes chemical ... See full profile

Pennsylvania (PA), USA

Expert in ISO 14001 EMS implementation, auditing and tailored training plus integration with GRI reporting
As a former member of TC 207 and former accredited EMS auditor, as well as an instructor of several accredited ISO 14001 Lead Auditor course providers, he was involved with ISO 14001 since the early 1990's - by way of the EMAS standard that one EU client ... 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 Food Labeling; Food, Spring/Bottled Water, Drug and Medical Device Good Manufacturing Practices
Expert was a California Food & Drug Investigator for 25 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. See full profile

California (CA), USA

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 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 Internet, Telecommunications, Software, and Protocols
Expert is a recognized expert in Internet standards, having written a number of standards in the IETF, including a number of SIP (VoIP), peer-to-peer, cloud computing, and messaging standards. In addition, he chaired a number of work groups developing ... See full profile

Virginia (VA), USA

Expert in Validation
Expert has been an independent Validation Consultant for around 10 years; he is responsable for the management of validation projects. He supervises resources acting as a project manager and is also responsible for the development and execution of ... See full profile

Puerto Rico

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