Drug-Development Expert (Pre-IND to Marketed Products), Pharmaceutical Development Strategy, Regulatory (Domestic and European)Full spectrum of drug development; (pre-IND to marketed products) and development of multiple pharmaceutical products.Global regulatory challenges in drug development and handling a wide range of drug development.Regulatory strategy and CMC strategy.Gap analysis and review of the CMC package.IND and pre-IND submissions.Pre-IN, IND, (Investigation New Drug), CTA, (Clinical Trial Approvals), IMPD, (Investigational Medicinal Product Dossier), NDA (New Drug Application) and MAA (Marketing Authorization Applications) s...

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-...

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...

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...

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...

Large Molecule Bioanalytical Consultant with PK, PD, and ADA experience. Over 20 Years Experience Developing and Validating Bioanalytical Methods to Support Drug Development Programs.  Experience in Summary  Accomplished bioanalytical scientist with extensive and diverse experiences in biotechnology and pharmaceutical industries.  Strong reputation for planning and organizing, analytical problem solving, multi-tasking. and coordinating team efforts.  Creative, collaboration and highly goal-driven scientist.  Expert in Ligand Binding Assays including immunogenicity. Successfully implemented complex acid...

Ph.D. Biochemistry Food and Nutrition Expert. Food Emulsion Biochemistry and Physical Chemistry, Fermentation and Coagulation within Non-Dairy SystemsNutritional food and beverage product development, bridging between chefs, food technologists, protein chemists and biochemists, and executives.Industry research planning, methods development, rapid prototyping, product development management and troubleshooting, patent applications, product upscaling, co-packer and business-to-business relations, and brand ambassadorship to both businesses and consumers.Product-specific reduction and elimination of eggs and dairy ingredients in a variety o...

Consultant in Computational Modeling. Drug Design, Proteins, Small Molecules, Genetics, Machine Learning, Artificial Intelligence, Bioinformatics and Biomedicine, Materials Discovery, Robotics & ContrSummary  Drug discovery consulting and research and development in Biomedicine. Providing over ten years in biomolecular computational methods (small molecules and proteins, proteomics, genetics).   Drug Discovery and Biomedicine - Health  High throughput virtual screening and docking. Drug candidate identification. QSAR (Quantitative Structure Activity Relationship) and QSPR (Quantitative Structure Property...

Ph.D. Fluorine Chemist with expertise in Molecule Synthesis Applications; Electronics (Fluorine Etchants, Deposition Agents), Pharmaceuticals (Fluorinated Steroids, Nucleotides, and Aromatics), Agricultural (Fluorinated, Herbicides, and Pesticides), Low-GWP Refrigerants and Foam Expansion Agents, Fluorosurfactants, and Inorganic Fluorine CompoundsFluorine industry chemist: Creating new molecules, developing new process technology, commercializing of new high-value products and providing over thirty years of experience.Electronics (fluorine etchants and deposition agents)Pharmaceuticals (fluorinated steroids, nucleotides, and aromatics)Agr...

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...