Chemical Engineer with extensive biotechnology experienceR&D Services: Chemistry, BiotechnologyLegal Services: Patent Services, Evidence Evaluation-technicalChemical Engineering: Process Troubleshooting, Process DevelopmentScale-up in bulk chemicals and dosage formsValidation in Manufacturing: Qualification of facilities and equipment IQ/OQ/PQIndependent Evaluations: manufacturing. processes, environment, safety, patents, waste management.Foster Wheeler, Chief EngineerScaleup of blood fractionation plant.Design comparisons for domestic and international plants.Safety audits and HAZOP...

Fermentation Expert in Compliance Activities, FDA API Manufacturing (US and European sites) Commercialization, FSMA PCQ1 trainer, Development of Procedures Laboratory Methodology and TrainingRegulatory support for organizations dealing with new product approvals and introduction, expanding operations, technology transfer, and changing customer, regulatory or certification requirements.FSMA (Food Safety Modernization Act) compliance in regulatory analysis, strategies and meeting deadlines.FSPCA Lead Instructor (Human Foods Certified and Animal Foods Certified), providing PCQI training to industry and regulatory agencies, including FDA.Preve...

Chemical engineer for front end process design specializing in polymers, refinery operations, chemicals and biochemical products.Chemical engineering consulting for 38 years with extensive global experience in the process industries, primarily related to polymers, refinery operations, chemical and biochemical products.Supervising start up and commissioning of new chemical plants.Lead chemical engineer of many projects, with responsibility for all aspects of planning, process design and supervision of other engineers.Process engineer on a nuclear waste disposal project in the United Kingdom.Experienced in fast track front-end process engin...

Medical Device, Medical Drug Delivery Design and Development for the Biotechnology and Pharmaceutical IndustriesAccomplished engineer/scientist with over 35 years’ experience in the design and development of drug products, pharmaceutical manufacturing processes and medical devices. Successful track record of progressing products from lab bench to commercialization. .Technical Competencies Drug product development and characterization, Process development and scale up, Project management, Identifying and managing vendors, CROs, CMOs, Tech transfer & trouble-shooting, Authoring CMC regulatory submissions, Development of micro-...

Dietary Supplement Formulation Consultant Specializing in Formulating Scientifically Backed Dietary Supplements;High-End Research, Supplements, New Custom Formulations in All Applications.Summary Pharmaceutical formulations with expertise in dietary supplement formulation. All high-end research-based supplements, including herbals, organic, CBD, women and children health, nootropics, sports nutrition, probiotic, energy blends and new custom formulations for all applications.  Dietary supplement formulation with ingredients that work on the human body in appropriate dosages. Modify existing formulas offering expert guidance for ingr...

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...

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...