Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments. Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals. Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...

Interpretation and Analysis of Technical Intellectual Property Related Documents in English and Japanese. Biochemistry and Cellular Biology Background in Biologics and Small Molecule Drug Discovery and Development. Drug Substance In Vitro Assay Development and StandardizationInterpretation and analysis of highly technical Japanese documents in English.Pharmaceutical and biotechnology research project management.Biochemistry - cellular biology background: Biologics and small molecule drug discovery and development.Liaison and interpreter for licensing and material transfers to and from Japanese organization.Manager of in vitro pharmacol...

Expert in Food and Beverage Packaging, Related Packaging Materials and Machinery.Food science and related food packaging materials and systems.Aseptic food packaging.Product and package interaction.Barrier plastic packaging.PET bottles filling above 190 F.Development of deep draw thin gage polypropylene block copolymer thermoformed trays for baked products.Retortable and hot fill plastic packaging; retortable microwavable shelf stable plastic packaging.Packaging technology assessment and commercialization.Consumer Packaging/Product Development. Certified by the Society of Packaging and Handling EngineersExpert Witness related to food pack...