Transitional Medicine-Protein Therapeutics and Nanobiotechnology Focusing Alzheimer’s, Brain Trauma & Cancer Through Drug Development, Nanoparticle based targeted-drug delivery of chemotherapeutics an  Recombinant antibodies (scFv, Fab), immunotoxins and antibody-drug conjugates (ADC), targeting characterization and pre-clinical testing in animal models. Expression, purification and characterization of biotherapeutics and testing in cancer xenografts in mice. Combinatorial phage library screening in disease models of cancer, brain diseases (Alzheimer’s, Traumatic Brain Injury) and drug-resistant bacterial infections. Transit...

Pharmaceutical Regulatory Consultant with Broad SNDA, GMP, API Development Experience.Development of commercial manufacturing, FDA and international registration and approval for atracurium besylate, trifluoridine, bupropion hydrochloride, zidovudine, exosurf, mivacurium chloride, doxacurium chloride, pseudoephedrine hydrochloride, acrivastine, valciclovir, tramadol hydrochloride, topiramate, levofloxacin, surfaxin, vinorelbine tartrate and lamotrigine.Major process SNDAs for ofloxacin and leucovorin calcium.Regulatory documentation and approvals (FDA request for NDAs for grandfathered products) for digoxin, melphalan, azathioprine, thiogu...

Consultant with Diverse Pharmaceutical Experience in Formulation Development, Manufacturing, Technology and Site Transfer, Process Design, Scale-Up, and ValidationPharmaceutical formulation development, manufacturing technology transfer, site transfer, process design optimization, and scale-up for domestic and international clients.Product development using QbD approach, process scale-up and optimization, process validation.Drive technology platforms such as solid and Liquid orals, aseptic filling, softgels, orally disintegrating granules, powders, MR products, X-ray contrast media, peptide injectable product, topicals, steroids and hormo...

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...

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...

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...