Designing, Commissioning, Qualification and Validation in the Pharmaceutical IndustryPharmaceutical standards regulations: BPF, BPL, GMP, Europ%uFFFFe Pharmacop%uFFFF and FDA 21CFR part.11.Quality assurance and the standards regulations requirements for the pharmaceutical industry.MethodologyRisk Analysis (AMDEC, HACCP)Six SigmaTechnical ExecutionPharmaceutical quality assurance and the standards regulations requirements.Design, quality, commissioning and qualification documentation of pharmaceutical processes.FAT, (Factory Acceptance Testing),SAT, (Site Acceptance Testing) commissioning, (re)qualification and validation tests.Aseptic pro...

Radiopharmaceutical Consultant Specific To: QA, QC, GMP, GMP internal Audits, Health Canada GMP Inspections and ExpertRadiopharmaceutical industry experience ranging from, Quality Assurance, (QA) Quality Control (QC), Good Manufacturing Practice (GMP), GMP internal audits, Health Canada GMP inspections, deviation handling and implementation of Corrective and Preventative Action (CAPA), change controls stability program, and validation. Oversee fast-paced radiopharmacy production environment. Quality Assurance Manager, applying over15 years of global experience in the radiopharmaceuticals industry. Demonstrated extensive and consistent...

Pharmaceutical: Drug Development and Deliverables, Project Management, Global Clinical Researcher, Medical Writing in Various Platforms, Provide Drug Product Reviews and Statistics ConsultingPharmaceutical development and deliverables: Print modules, slide decks, annotated prescribing information, storyboards for digital media for use in the training of sales force and medical science liaisons. Medical literature identification and interpretation, clinical studies, therapeutic guidelines, prescribing Information, and market research. Drug products evaluation, drug statics and author of technical medical reports. Project proposals and...

Analytical chemist expert in development, validation and transfer of methods for pharmaceutical regulatory filings such as IND, ND, NDA, eCTDSeparation science HPLC, ion chromatography, chiral HPLC, GCAnalytical method development and validation analytical method technical transferLaboratory equipment and instrument qualification and calibrationDesign and setup of GMO and GLP Analytical LaboratoriesRaw material and drug substance characterizationPhysical chemical characterization and structure elucidationProject management for bioanalytical and analytical laboratoriesBioanalytical method developmentQuality assurance for GMO and GMOP labora...

Strategic Chemical and Specialty Chemicals Technology Management: New Drug Applications and DevelopmentGuiding clients through complex chemical technology development programs.Identifying new technology enabling business opportunities, process improvements, debottlenecking opportunities, and planning capital upgrades to increase productivity of specialty chemical plants.Defining the content of the(CMC) Chemistry Manufacturing Controls component of new drug applications (NDA) and developing the strategy for completion of necessary work in individual technology areas.Leading the effort to develop a guiding vision and organizational structur...

Ph.D. Pharmaceutical-Nutraceutical Formulator and Consultant for Industrial Pharma and Nutraceutical, Tablets, Capsules, Health Foods, Soft Drinks, Diary, Snacks, Nuts and Seeds, Gums in Food Products, Pectins,Nutraceutical and pharmaceutical formulation and manufacturing.Formulating hemp Cannabidiol (CBD) products.Pharmaceutical Formulation Scientist with prior industry, FDA experience in CMC writing for small molecules and biologics for both FDA and EMA.Tablet and capsule formulation, manufacturing, trade secret infringement, product labeling, and patent evaluation.Formulation and manufacturing of food, nutraceutical, and pharmaceutical...

Toxicology Consultant Specializing in Inhalation, In Vitro and High Content Screening, Consumer Product Additives, Tissue Regeneration Research, Cancer Cell Biology, Nutrition Research, Preclinical, Experimental Design and AnalysisPreclinical toxicology of consumer products. Design and manage external toxicity studies and summarize study reports. Research on natural compounds and cancer reversion, and toxin induced pathways involved in disease. Inhalation, reproductive, and in vitro toxicology. High content screening assays and new in vitro toxicology assay development. Proof-of-concept for new products, and regulatory toxicology (F...

Pharma DMFs Compilation, Review and Filing in Various Regulatory Authorities and Marketing Procedures (CP/DCP/MRP/NA) i.e., Europe, EDQM, USFDA, TPD-Canada and TGA-Australia with Accordance to Filing Drug Master File (DMF)/ Active substance Master File (ASMF) for the domestic and global industries. USDMF: United States Drug Master File, (Open and closed part). Certificate of Suitability (CEP-COS) of EDQM. eCTD Compilation. DMF-Life cycle management. Technical Packages for Pharma Intermediates. DMF review as per ICH guidance. Analytical Method Validation and Development for API (Active Pharmaceutical Ingredients) and Pharma Interme...

Medicinal Chemist Consultant for API Process Research, Development and API Process Start-upSynthetic organic chemist and small scale chemical process research and development.Chemical process research and development for "small molecule" drug substances.Guidance for scale-up to provide material for Phases 1 - 3 and manufacturing.Pharmaceutical facility start-up troubleshooting.Assistance with CMC section of filings.Pharmaceutical laboratory process research leading to technology transfer and scale up.Design and implementation of practical, cost-saving, processes and procedures.Experienced with 12 hands-on manufacturing start-ups of drug su...

Over 30 years in the Pharmaceutical Industry, Beginning to End of Life-Cycle Management Consulting. Effective Expertise; Finding Solutions to Problems, Increasing the Efficiency of Development Summary  Pharmaceutical industry focus of new product development through life-cycle management, supplying over 30 years of industry experience in; efficient development, scale-up, transfer, problem solving, and commercial manufacture of pharmaceutical products. Formulation Scientist and Manager with emphasis in: CMC documentation, technology transfer, drug delivery, and process analytical technology. Appling technical expertise to problems...