Pharmaceutical Regulatory Strategy Assessment, Development and Execution for Novel Therapeutics, Interactions with Regulatory Authorities and Regulatory Due DiligenceStrategic regulatory aspects of the development of novel therapeutics encompassing initial registration - approval and life-cycle management of multiple pharmaceuticals (in multiple therapeutic areas).Planning and execution of interactions with regulatory authorities (esp. US FDA).Regulatory due diligence review and appraisal of therapeutic development programs, regulatory aspects in the development of a pharmaceutical for the legal defense.Regulatory due diligence input on po...

Pharmaceutical Formulation Development and Process Development ScientistPharmaceutical formulation development and process transfer, serving over twenty five years' in the pharmaceutical industry.Develop products; solid dosages, liquids, capsules, research new technologies, and sustained release technologies.Experience with formulation, validation and scale up of all the above named disciplines.Supervisor and Manager responsible for staff consisting of formulators, packaging engineers, and equipment engineers.Clinical supply manufacturing and troubleshooting processes with successful transfer to process engineering and then to manufacturin...

Chemical and Biopharma Trade Consultant, Licensed Customs BrokerOrganic and medicinal chemist with import, export, and economic sanctions experience. Provides import (Harmonized Tariff Schedule) and export (Schedule B and ECCN) classifications. Assists with import requirements of partner government agencies e.g. USDA, FDA, FWS. Chemical and biopharmaceutical product import classifications for the global Harmonized Schedule (HS) and the Harmonized Tariff Schedule of the United States (HTSUS). Export control regulatory compliance of the U.S. Department of Commerce, Bureau of Industry and Security (BIS). Export classifications to give Sc...

API Quality Assurance, SOPs, batch production records and protocols, CAPA and SMF Activities, Clean Room ValidationsCompliance to cGMP Systems and Regulatory requirements. Application risk assessment, as applicable at various QMS documentation. Review of all the SOPs, batch production records and protocols (validation and qualifications) prior to the approval along with change request forms. Review of all equipment qualification documents like reactors, centrifuges, different types of dryers, blenders, powder process equipment etc., (DQ, IQ, OQ, PQ) and related test reports. Review of clean room HVAC qualification documents and relat...