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...

Pharmaceutical Expert for Drug Portfolio Analysis, Drug Competitiveness Assessment and Overall Drug Development and Growth StrategiesPharmaceutical and Biotechnology Drug DevelopmentMarketing, product lifecycle management.Pharmaceutical portfolio analysis.Drug clinical trials, FDA filings, FDA strategy.Technology and product licensing, business development, transactions.Business and commercial analysis, market assessment, market research.Forecasting, valuation and drug portfolio management.Intellectual property.BiotechnologyBiogeneric development and market entry.

Canadian regulatory affairs expert prepares pharmaceutical and medical device submissions and audits manufacturing quality practicesPharmaceutical Good Manufacturing Practices (GMP) for Canada.Regulatory Affairs Canada, submission preparation.Change control and complaint management.Pre-approval inspections.Pharmaceutical Quality Systems, clinical trial supplies.Qualification and validation: process, equipment, cleaning and test methods.Water for pharmaceutical purposes.Bioanalysis.Adverse event management; deviation and out-of-specification investigations.Sterile product manufacturing; environmental monitoring.FDA, QA, QC, quality assuran...

Pharmaceutical Licensing Expert and Licensing Consultant With Technical Management ExperiencePharmaceutical licensing executive with a strong research and development background.Experience with numerous diverse deal structures supporting research collaboration and fund raising.Identify and evaluate in-licensing opportunities across all therapeutic areas including neuroscience, cardio-pulmonary, anti-infectives, inflammation and oncology.Undisclosed Company, Managing Director, 2008 - PresentBiotechnology and pharmaceuticals business development cons...

Pharmaceutical management, manufacturing in China, supply chain expertise and coordinating major capital projects, new product introduction and new business development.Pharmaceutical technical operations with diverse international experience.Pharmaceutical management, manufacturing, supply chain, major capital projects, new product introduction and business development, with a focus on China.Particular expertise in operating at strategic levels in international and multicultural environments.Capital project management, site selection and team leadership.cGMP, regulatory affairs and compliance experience.

Pharmaceutical Patent Attorney: Patent Strategies, Pharmaceutical and Biotech R&D, Patent Litigation and Expert WitnessExpert in planning and executing pharmaceutical and biotechnology research and development strategies.Experienced Hatch-Waxman litigator from a corporate point of view.Prepared witnesses and attended depositions for corporate personnel.Conducted due diligence for possible in-licensing candidates.Negotiated and drafted licensing agreements.Familiar with FDA regulations as they pertain to NDA's and sNDA's.Patent strategy, patent portfolio management and patent assessments.Skilled at Paragraph Four Patent litigations.Drafte...

Medical Device Design and Product Development Expert Specializing in Class III and Class IIb Devices (Coronary and Peripheral Bare Metal Nitinol, SS, Cobalt Chromium and Drug Eluting Stents and Balloons, Scoring Balloon Catheters, Vascular Grafts, Hemodialyzers)Medical device design, product development and commercialization experience of 21 years with a record of building and leading high performance product development teams, developing and commercializing new products, and driving increased revenues and profitability.Successful track record in large (Medtronic, Baxter) and start-up (AVE, AngioScore, NanoVasc) corporations.Research, prod...

Intellectual Property Strategy Expert for Small and Start-Up BusinessesUnited States Patent and Trademark Office registered patent agent.Registered and qualified to file and prosecute patents with the USPTO.Fluoropolymer and expanded fluoropolymers (PTFE) materials.Intellectual property trainer, including training for patents, trade secrets, and business practices.Intellectual property agreement preparation, including confidentiality and service agreements.Professional prior art and patent searcher.Freedom to operate analysis.Undisclosed Company, President, PresentCompl...

Innate and Adaptive Immunity, Inflammation, In Vitro and In vivo models. Biochemistry, Protein Modification, Signal Transduction, Gene RegulationBiochemistry, protein chemistry, and protein modification.Immunology, toll receptors, vaccines and vaccine adjuvants.In vitro and in vivo models of disease.Forecasting and determining future needs in pharmaceutical and biomedical industries.Research for development of 3M TLR agonists, created new opportunities as vaccine adjuvants and cancer therapies.In vitro and in vivo immune response and oncology models to demonstrate efficacy.Widely acknowledged for innovation and creativity to identify pharm...

Large and Small Molecules Pharmaceutical: Development, Branding, Strategy, Licensing, and Licensing Expert.Pharmaceutical marketing, strategy, and product commercialization leader with over 15 years of experience in pharmaceuticals small and large molecules commercial representation on development teams.Commercial aspects of product development from preclinical through post-launch phases and in identifying key unmet needs and defining market opportunities.Strategic and commercial analyses with actionable recommendations for products, business development, markets, research and development, and portfolios.Proven ability to optimize a produ...