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DABT Toxicologist and Scientist with Applied Industrial Experience Specific to IND and NDA Submissions to the FDA and Global Equivalents. - Technical Consultant #1100

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 products - Technical Consultant #1342

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...

Pharmaceutical and Health Care Consultant Specializing in Cardiovascular Drug Development, Drug Safety, and Medical Writing - Technical Consultant #1461

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...

AIF(Italian Medicines Agency) and EMEA (European Medicine Agency) Certified Physician promoting drug therapy for Alzheimer's, Amnesia, and Cardiovascular Diseases - Technical Consultant #1525

Medical Doctor focused on cures for short term memory lossCentral cholinergic mechanisms (nucleocortical and septohippocampal pathways) related to the learning process and short-term memory in normal and aged brains.Experimental models and tests of acetylcholine as a neurotransmitter in learning and memory loss.Screening of compounds (such as pyroglutamic acid, oxiracetam, aniracetam and pramiracetam) with the potential of use in humans for Alzheimer's disease and other age-associated memory impairments.Expertise in European pharmaceutical research and development and common technical documents.Managing and monitoring Phase 1 and 2 clinica...

Pre Approval and Post approval Pharmaceutical Expert in the Canadian Market - Technical Consultant #1659

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,...

Medical Doctor with Expertise in all Phases of the Drug Development Process for Pharmaceuticals, Devices, and Dietary Supplements - Technical Consultant #1733

Medical Doctor with Expertise in all Phases of the Drug Development Process, Including Medical, Legal and Policy Issues Related to Pharmaceuticals, Devices, and Dietary SupplementsAll phases of the drug development process, including medical, legal and policy issues related to pharmaceuticals, devices, and dietary supplements.Therapeutic areas included asthma, epilepsy, cancer, cardiovascular disease, infectious disease, sleep, depression, and prostate cancer.Drug development initiatives, protocol development, data analysis, review and revision submission materials and manuscripts, safety data review, medical monitoring, and medical review...

Toxicology, Drug Development, and Clinical Pharmacology Expert - Technical Consultant #1915

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...

Toxicologist: Pharmaceutical, Nutraceutical and Consumer Healthcare Products - Technical Consultant #1949

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...

Pharmaceutical Manufacturing and Regulatory Compliance Expert - Technical Consultant #2068

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 - Ophthalmology, Rheumatology, Dermatology, Cardiology, and Gastroenterology - Technical Consultant #2059

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...