Leading Product Creation Though CE/FDA Submission, ISO, MDSAP Audit, R&D Documents (DHF): DI, DO, Risk, V&V plan, Protocols and Reports. Quality Procedures Implantation, Quality & Regulatory BinderAssurance, Quality Control, and Regulatory Affairs Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820). CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies. Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different...

Doctorate in Biochemistry Experience in Academics, Biomedical Research, Process Development (Upstream and Downstream) of Bacterial Vaccines and Protein Therapeutics for Scale Up to ManufacturingIndustrial Biotechnology  Biotechnology facility design and layout, overall planning, project conception, budgeting and execution.  Over twenty tears of industrial experience in-process development of vaccines and biologicals in leading companies.   Research and development biotechnology management and transfer. Process development and optimization for bacterial vaccines.  Vaccine’s manufacturing unit layout an...

Pharmaceutical Certified Quality Auditor with Focus to: Document/Data in Quality Management System, cGMP, GLP, GCP, ICH, EP, USP, NF, DEA, SOPs and ProtocolsExperienced cGMP and ASQ Certified Quality Auditor (CQA) solving quality issues and improving quality systems. Document/Data auditor for Quality Management System, cGMP, GLP, GCP, ICH, EP, USP, NF, DEA, SOPs and protocols. FDA compliance in a pharmaceutical environment; FDA regulations including 21 CFR 11, 120, 210/211, and 820; plus, ISO 13485. Demonstrates proficiency in reviewing, editing, and writing SOPs, ensuring accuracy, clarity, and compliance with all applicable guideli...

Consultant for Pharmaceutical Marketing Research and Drug Program ManagementSenior consultant with 15 years of research experience in academic and industrial settings with a Ph.D. in Immunology.Marketing research of competitive assessment of pharmaceutical market segments and geographical regions.Pharmaceutical and biotechnology drug development, drug company portfolio analysis, strengths, weaknesses and opportunity assessment.Pharmaceutical and biotechnology drug and intellectual property valuation.Clinical trials, FDA filings, product lifecycle management and project management.Experience in collaborating with customers, at different le...

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...

Plastic Compounding Consulting Expert with Twin-Screw Extrusion and Plastics Testing Laboratory and Underwriters Laboratories Experience and Significant Far East Experience30 years of plastics testing and consulting businesses with continuing Asian technical and business contacts. In-depth technical and operations knowledge of plastics processing and compounding. Formulations expert in polyethylene (PE), polypropylene (PP), polybutylene terephthalate (PBT), nylon, polycarbonate (PC) and alloys, acrylonitrile-butadiene-styrene (ABS) and other engineering resins. Process design and experience in single screw, twin screw and FMC compound...