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Pharmaceutical Auditor: cGMP Auditing, AMP Compliance, CMC Preparation, Veterinary Drugs, Product Formulation, Software Validation - Technical Consultant #430

cGMP Auditing, AMP; Compliance, CMC Preparation, Veterinary Drugs, Product Formulation, Software ValidationcGMP audits & amp; compliance evaluations, CMC document preparation, product formulations & design, package development, software validation, veterinary drugsExpert in: cGMP audits and compliance evaluations, CMC document preparation,product formulation and design, chemical supplies management, contractor management, package development, software validation, and veterinary drugs.Rebuilding businesses, restructuring organization and moving into new manufacturing facility.Built quality systems, rewrote SOPs, designed and implemented...

National and International Pharmaceutical Development Expert: Research and Development, Drug Manufacturing, FDA Regulations, IND, NDA , cGMP, Compliance and Validation - Technical Consultant #705

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.

Formulation and Manufacture of Products Based on Softgel Capsule Technology - Technical Consultant #915

Polymer Consultant Expert in Softgel Capsule Technology and Paint Ball Formulation and ManufacturingSoftgel capsule technology for pharmaceuticals and recreational products.Chemical research related to medical polymers, analytical methods and personal care and cosmetic product formulation.Formulation of paintball fills, shells and colors.Paintball manufacturing technology.Independent Consultant, 2000 - PresentPolymer processing and paintball manufacturing technology.R. P. Scherer, Clearwater, FL, Technical Service Scientist, 1993 - 2000Devel...

General Management of Pharmaceutical R&D for a MajorCorporation - Technical Consultant #939

Experience in domestic & international pharmaceutical research, development and general management of ethical & OTC pharmaceutical products and technologyThirty years of experience in domestic & international pharmaceutical research, development and general management of a broad range of ethical and OTC parmaceutical products and technology.Strong goal orientation, effective communication skills, proven track record, and bottom-line accountability.Significant contributions to business-wide strategic goal setting, improvement processes, outsourcing, and vendor selection.

Drug development, Drug Delivery and Quality Assurance Expert - Technical Consultant #1149

Seasoned pharmacists with years of experience in drug development, drug delivery, controlled release and statistical quality assurance of production.Expert in managing drug product development of new chemical entities, novel drug delivery systems (film coated tablets, chewable tablets, rapidly disintegrating tablets, effervescent tablets, controlled release tablets, liquids, suspensions, parenterals, etc.). Highly experienced in formulation development, quality assurance, PAIs, and authoring NDA/CMC documents.Thoroughly familiar with GMP, GLP, and FDA expectations.Pharmaceutical Product R&DDrug DeliveryStatistical Optimization of Pharmace...

Consultant for Pharmaceuticals and Nutraceutical Regulatory Compliance - Technical Consultant #1362

Expert for Pharmaceutical Equipment Sales and DistributionFormulation process development of pharmaceuticals and nutraceutical dosage form.Tablets, capsules, injectables, creams, ointments and controlled release products.Regulatory requirements for pharmaceutical and nutraceutical including FDA, DMF, NDA, ANDA, cGMP, SOPs, auditing, labeling.Process controls including validations, operations, specifications, equipment selection, and qualifications, IQ/OQ/PQ.International liaisons/licensing of pharmaceutical and nutraceutical raw materials, finished products.Sales and marketing including setting up broker, distributor, retailer network, new...

Pharmaceutical Consultant Specializing in Preformulation, Pilot Plant Laboratories, Regulatory Compliance, Pharmacokinetics, Diabetes Medicinal-Chemistry and Expert Witness for Pharmaceutical Patent Litigation - Technical Consultant #1394

Licensed Pharmacist Skilled with Patent Litigation and Pharmaceutical Product Development Projects, Including Regulatory IssuesExpert Witness for pharmaceutical patent litigation.Pharmaceutical reformulation and the physical-chemical characterization of new chemical entities (NCE) and APIs.X-Ray diffraction, polymorphism, solubilization, stabilization and kinetics of pharmaceutical materials.Author of regulatory (IND/NDA/CTD) CMC sections and support documents.Project planning and management for pharmaceutical development projects, including virtual contract research (CRO) companies.Pharmaceutical method development preformulation and pilo...

Pharmaceutical Compliance Consultant: FDA Regulations & Submission with Management Experience at Indian Pharmaceutical Companies - Technical Consultant #1393

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...

Microbiology and Drug Delivery Systems Consultant - Technical Consultant #1406

Functional properties of IgA. Development of oral vaccine delivery technologies. Effectiveness of host-parasite relationships. Mechanisms of adherence and pathogenisis. Development of oral drug delivery systems. Development of biodegradable nanoparticles, tumor targeting agents, transdermal drug delivery systems, and oral nanolattices for protein drugs.Functional properties of IgA.Development of oral vaccine delivery technologies.Effectiveness of host-parasite relationships.Mechanisms of adherence and pathogenisis.Transport of macromolecules across the intestinal epithelium.Receptor mediated endocytosis.Isolation, purification and refoldi...

Validation and Regulatory Pharmaceutical Consultant - Technical Consultant #1431

Developing and validating standards for pharmaceuticals and biopharmaceuticals. Technical and regulatory aspects of pharmaceutical and biopharmaceutical development and manufacturing including analytical and bioanalytical characterization as well as stability testing and formulation development. Audit and FDA experience.Developing and validating standard and state of the art analytical methods to characterize pharmaceuticals and biopharmaceuticals.Expert in liquid and gas chromatography, capillary electrophoresis, spectrophotometry and mass spectrometry (single and triple quad and MALDI and ion - trap).Developing and validation of biologi...