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...

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...

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.

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...

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 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...

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...

Pharmaceutical Consultant Specializing in Drug Dissolution, Liquefaction, Laboratory Management and Regulatory ComplianceDissolution (reduction to a liquid form; liquefaction) method development, validation, transfer and troubleshooting.HPLC method development, validation and transfer.Laboratory instrument qualification and calibration.GMPs/ICH/USP: laboratory Quality Assurance and regulatory inspection readiness.Regulatory specification development.Preparation of the CMC (Chemistry, Manufacturing and Controls) section of IND (Investigational New Drug) and eCTD (Electronic Common Technical Document).Development of SOPs and Quality System...

Dosage From Pharmaceutical Consultant: Facilities Management and GMP ComplianceFormulation and process development of multiple types of pharmaceutical dosage forms.Research and development, optimization, manufacturing and packaging of solid, liquid and powdered dosage forms.Scale up and technology transfer of multiple dosage forms.Equipment and processing knowledge, product processing/equipment trouble-shooting and facility validation and qualification activities.Identifying and implementing significant operational cost savings in pharmaceutical operations.Auditing of diverse cGXP operations (API manufacture, laboratory operations, clinica...

Drug Stability and Drug Quality Consultant and Analytical ChemistProduct experience includes brand, generic and drug substance (active pharmaceutical ingredient, API); small molecules, biologics, vaccines; Rx and OTC products; oral, topical, and parenteral dosage forms.Pharmaceutical compliance and remediation, quality systems management, data integrity audits, product quality assessments, gap assessments, batch reviews, laboratory and manufacturing oversight.Authoring of policies, procedures, training programs. Technical and business writing, editing, and proofreading: Proposals, quality agreements, standard operating procedures (SOPs), p...