Pharmaceutical chemist experineced in regulations and good manufacturing procedures.Drawing on expertise in the areas of:FDA regulationsNew Product DevelopmentMarketing Research and MarketingFinancial Aspects of Product DevelopmentFormed my own business. Served clients in the areas listed. Interfaced with FDA on such issues as: establishing Drug Master File (DMF), chemicals extracting from package into medicinal preparation, validation procedures, etc. Prepared and delivered training seminars on Effective Communications, Negotiating Techniques, Business Aspects of the Technical Function, Strategic Planning, and delivered seminars for other...

Pharmaceutical Chemist and Former FDA Manager GMC, FDA Compliance and Expert WitnessRegulatoryFood and Drug Administration compliance.Prepare submissions to the Food and Drug Administration.Quality audits and implementation of changes.Simulated FDA inspection - quality and readiness audits.Establish and review quality assurance procedures for GMP and GLP.Develop and write appropriate Standard Operating Procedures (SOPs).Assist firms with Consent Decrees, Warning Letters, and 483s.Chemistry, Manufacturing, and Controls (CMC) expert.TechnicalLaboratory procedures and documentation.Pharmaceutical package and labeling and product compatibility...

Worldwide Pharmaceutical Expert Providing: Coordination and Technology of Pharmaceutical Products and Formulation and Development of Solids and ParenteralsSummaryExpertise in global product development, technology transfer/validation and business development.Designed and implemented development and registration strategies in U.S. and International arenas.Significant experience with all pharmaceutical dosage forms including peptides and novel delivery systems.Expert WitnessTwenty years of experience as an expert witness for pharmaceutical and formulation matters.

Senior consultant in pharmaceutical and medical devices with emphasis in blood testingPharmaceutical and biotechnology quality assurance and control (QA, QC.)Regulatory compliance, consent decree and FDA batch record reviews-investigations; European audits.Plasma and blood collection centers and computerized donor record files.Blood and plasma quality assurance and control.Pharmaceutical QC methods development and review.Pharmaceutical validation of laboratory methods.Quality systems, quality control laboratory and development of standard operating procedures.Regulatory compliance audits; quality system audits.Vaccine stability, raw materi...

Consultant in Drug Discovery and Development; Preclinical and Clinical Drug Metabolism and Pharmacokinetics, Toxicokinetics, and Clinical Pharmacology; Preparation and Submission of IND's/ERC's and NDA's/MAA's.Over 35 years of experience in the discovery and development of novel drugs in multiple therapeutic areas (anti-bacterial, anti-inflammatory, anti-viral, cardiovascular, central nervous system, oncology, ophthalmic, pulmonary, and renal).Strong managerial and leadership skills with scientific expertise in the areas of drug discovery and development, preclinical and clinical drug metabolism, pharmacokinetics, and clinical pharmacology...

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...

Expert in analytical chemistry for pharmaceuticals, FDA issues and detection of bio hazards for Homeland SecurityCenter for Drug Evaluation and Research (CDER), former FDA employee.FDA review of new drug (NDA) and generic drug (ANSA) application submissions, FDA national Field operations, FDA compliance.Research and development programs related to homeland security.Department of Defense force protection and agent detection (novel devices, sensors and samplers) for the detection and identification of chemical and biological agents.Technology related to infectious disease countermeasures.Analytical chemistry related to drugs.Pharmaceutical a...

Pharmaceutical Compliance Consultant: FDA Regulations & Submission with Management Experience at Indian Pharmaceutical CompaniesPharmaceutical quality assurance and regulatory affairs.Skilled in Indian pharmaceutical research and development with leadership positions at Ranbaxy Laboratories, Strides Arcolab, Unilever and Ciba Geigy, all in India.Pharmaceutical GLC and GMC compliance audits, QA operations and regulatory submissions.Pharmaceutical quality control for analytical equipment, method development and validation.Synthesis of active pharmaceutical ingredients (API) and API isolation, identification, impurities and degradation produ...

Pharmaceutical Drug Development Expert: Scale-up, Technology Transfer, Process Optimization, Troubleshooting, Clinical Supplies, FDA and ICH Quality and ComplianceManaging pharmaceutical operations, process and analytical methods development.New pharmaceutical product formulation development, scale-up, process start-up, optimization and troubleshooting.FDA-recognized expert in formulation development and technology transfer.Pharmaceutical licensing, Regulatory Affairs (CMC), quality systems and staff management.

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,...