PhD with expertise in Pharmaceutical Assessments, Investigations, 3rd party certifier, and Regulatory; FDA EMA, MHRAOver 33 years' experience in quality, microbiology and regulatory affairs.Pharmaceutical assessments, prioritization, establishment of realistic timelines for the implementation of consent decree commitments and 3rd party certifier of deviations-investigations.Ensure the robustness of quality systems - change control, product complaint handling, revision of SOPs, and control of 3rd parties.Quality assessment of sterile injectable, small molecules and biological as well as other dosage forms.Solid and liquid oral dosage forms...

Analytical Chemistry Consultant Specializing in Drug Stability and cGMP, FDA, and ICH Quality and ComplianceManage pharmaceutical commercial internal-external stability programs providing, guidance for laboratory investigations, input for laboratory information management systems, support sample management programs, and support data review. Provide support to Operational Excellence Projects.Ensuring stability studies are conducted to support regulatory commitments.Communicating trending stability data from the QC laboratory and contract laboratories.Drug stability program management for development and commercial products.Statistical anal...

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-...

Biologics Pharmaceutical Development and Manufacturing Consultant for Clinical and Commercial Products. Formulation Development Work and Stability Testing, from Early Stage Through Commercial, for Proteins, Monoclonal Antibodies, Vaccines and Small Molecules.Biologics pharmaceutical development and manufacturing, working in process development, purification, formulation, lyophilization, analytical development and stability for both clinical and commercial products.Formulation development work and stability testing, from early stage through commercial, for proteins, monoclonal antibodies, vaccines and small molecules.Sterile fill support f...

Nutraceutical, Health Foods, Dietary Supplements and OTC Products Consultant. Custom Formulations for Dietary Supplements and OTC Products; Solid, Semisolid and Liquid Delivery. Sample Development, Research and Development, Raw Materials Sourcing and Specifications.Nutraceutical, Health Food, Pharmaceutical, and Medical Devices, new product development and research and discovery.Nutraceutical formulation development; Identifications and evaluation of new materials; process quality and improvement; quality system; and technical support.Dietary supplements and OTC product formulation.Ingredients sourcing for dietary supplements.Raw materia...

Pharmaceutic Analytical Chemistry Consultant Expert in Drug Stability and Identification of API and Chemical Materials, (Pharmaceutical Chemist Expert on Forced API Degradation Studies and Drug Stability)Leadership of multi-scientist group responsible for the analytical characterization of drug substance and drug product formulations.Analytical method development and validation, drug substance and drug product characterization, stability evaluation, and analytical research and development project management.Broad background in the areas of physical-organic chemistry and analytical chemistry, chromatographic (HPLC, GC, SEC, Chiral) and spe...

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...

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...