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...

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...

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...

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...

Ph.D Pharmaceutical Regulatory and Laboratory Compliance, Quality Assurance and Controls (cGMP, FDA, ICH, EMA, ISO) ConsultantPharmaceutical and biotechnology product development, management of cGMP compliance quality systems, quality control, quality assurance, (in unique dosage forms, and sterile-nonsterile processing methods).Laboratory quality systems for both pharmaceutical development and quality control testing.Complete laboratory outfitting including qualification and method implementation.Test method development, transfer and validation.Analytical measurement and techniques.Auditing systems and processes.Analysis of APIs, raw mate...

Pharmaceutical Drug Development Expert: Scale-up, Technology Transfer, Process Optimization, Troubleshooting, Clinical Supplies, FDA and ICH Quality and ComplianceManaging pharmaceutical operations, process and analytical methods development.New pharmaceutical product formulation development, scale-up, process start-up, optimization and troubleshooting.FDA-recognized expert in formulation development and technology transfer.Pharmaceutical licensing, Regulatory Affairs (CMC), quality systems and staff management.