CMC Consultant Specializing in the Development of Small Molecule Therapeutics (Analytical, Chemistry, and Formulation)Physical and analytical chemistry for CMC support of small molecule drug development.Chemical and formulation process development for API and various dosage forms.Material characterization of API and dosage forms for process development and troubleshooting.Analytical development, method validation and transfer for development and commercial methods; data analysis and interpretation of trends.Coordination of CMC activities with toxicology, clinical, QA/QC and regulatory affairs line functionsProject and supply chain manageme...

Compliance Consultant in Chemical and Biopharmaceutical sectors. Focus to Chemical and Biopharma Material Import and Export Classifications, Import Requirements, Export Controls,& Economic Sanctions.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 Schedule B and Export Control Classification Numbers (ECCN) Customs (CBP) import regulatory compliance for partner government agenci...

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...

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...