DABT Toxicologist and Scientist with Applied Industrial Experience Specific to IND and NDA Submissions to the FDA and Global Equivalents.DABT Toxicologist and Scientist, Department Head with over 12 years applied industrial experience, supporting and directing interdisciplinary teams to both IND and NDA submissions to the FDA and global equivalents.Management, budgetary and scientific skills include discovery, investigative, and regulatory drug safety assessment with an excellent foundation in toxicology, pharmacology, physiology, biochemistry and DMPK.Therapeutic areas supported are anti-infectives, cancer, immune regulation, diabetes, CN...

Drug safety and medical director with experience in cardiovascular, endocrine/metabolism, anti-infective and dermatological productsClinical development and drug safety, epidemiological and outcomes research, business development and product acquisitions of 30 years with a variety of clinical practices.Physician practice includes: Pediatric and general medicine ICU/NICU, ward, emergency room, clinics, and research center management.Global pharmacovigilance ranges across all therapeutic areas of drug development, including but not limited to: cardiovascular, anti-infectives, metabolism and endocrinology, oncology, respiratory and allergy, v...

Consultant for drug development for cardiovascular therapeutics and heart failure; experienced as an expert witness.Drug development, specializing in cardiovascular therapeutics.Expert witness and the evaluation of cardiovascular drugs.Drug safety.Medical writing: Protocols, study reports, manuscripts, FDA submission (NDA) briefing documents and investigation of new drugs (IND).Product support-promotional review and medical information.Evaluation of previously monitored clinical studies.Principal Investigator in the following areas:Vasodilator and inotropic drugs.Vasodilator therapy for acute myocardial infarction.Nitrates and hydralazin...

Canadian License Applications for Natural Health Products, Cosmetics and PharmaceuticalsPerforming key pre approval and post approval activities for drugs intended for the Canadian marketplace.Preparation of DIN applications for submission to Health Canada.Product license and site license applications and amendments for natural health care products.Drug establishment licenses for Canadian importers, packagers and distributors.Responses to Health Canada deficiency notices.Expert WitnessRelated to Notice of Compliance (NOC) issues.Independent Consultant,...

Over 30 Years of Experience in Pharmaceutical Research and Development. Expert Support in Clinical Pharmacology, Toxicology, Drug Development, Regulatory Affairs and Clinical Research at Major Pharmaceutical CompaniesOver 30 years' experience in pharmaceutical research and development.Clinical pharmacology, toxicology, drug development, regulatory affairs and clinical research at major pharmaceutical companies.Led the research teams that discovered and developed misoprostol (Cytotec®), a worldwide anti-ulcer drugWorldwide clinical research at major pharmaceutical companies.Educator: Pharmacology and toxicology to medical, dental and p...

Board Certified Toxicologist: Pharmaceutical, Nutraceutical and Consumer Healthcare ProductsFocused toxicity investigations in the consumer health, nutrition pharmaceutical and product safety industries.Drug and food ingredient preclinical development, (all phases) and healthcare products (OTC and personal care products).Product safety and product regulatory consultant frequently interacting with FDA, EPA, international regulatory agencies, U.S. and foreign pharmaceutical and chemical companies.Risk assessments and management of preclinical development and regulatory programs for pharmaceutical, nutraceutical, consumer healthcare, and ch...

Global Pharmaceutical Creation and Implementation of Systems to Increase Efficiency, Sustain Regulatory Compliance, Interpretation of Regulatory Requirements: Quality Systems, cGMP, Good Laboratory Practices, IND/NDA/ ANDA/ DMF and CAPAGlobal market place creation and support; implementing systems, increase efficiency and sustain regulatory compliance in the pharmaceutical industries.In-depth knowledge and interpretation of regulatory requirements as applied to quality systems, cGMP, Good Laboratory Practices, laboratory equipment expertise.Vendor assurance programs, stability programs, validation (equipment, process, and analytical), manu...

Pharmaceutical and Biotechnology Medical Affairs Consultant. Scientific Reviewer of promotional and advertising materials for existing brands, new products, press releases, educational materials, field training materials. Expertise in Ophthalmology, Rheumatology, Dermatology, Cardiology, and GastroenterologyStrategic Advisor and support in in multiple therapeutic areas including: Ophthalmology, Rheumatology, Dermatology, Cardiology, and Gastroenterology.Clinical and Scientific Reviewer of promotional and advertising materials for existing brands, new products, press releases, educational materials, field training materials.Scientific conte...

Regulatory Pharmaceutical Compliance Consultant with Expertise in Clinical, Pharmacovigilance, Biologics, Biosimilars, Orphan Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic, and Food.Regulatory strategy, pathways and gap analyses.Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, a...

Consultant with Diverse Pharmaceutical Experience in Formulation Development, Manufacturing, Technology and Site Transfer, Process Design, Scale-Up, and ValidationPharmaceutical formulation development, manufacturing technology transfer, site transfer, process design optimization, and scale-up for domestic and international clients.Product development using QbD approach, process scale-up and optimization, process validation.Drive technology platforms such as solid and Liquid orals, aseptic filling, softgels, orally disintegrating granules, powders, MR products, X-ray contrast media, peptide injectable product, topicals, steroids and hormo...