Drug Stability and Drug Quality Consultant and Analytical ChemistProduct experience includes brand, generic and drug substance (active pharmaceutical ingredient, API); small molecules, biologics, vaccines; Rx and OTC products; oral, topical, and parenteral dosage forms.Pharmaceutical compliance and remediation, quality systems management, data integrity audits, product quality assessments, gap assessments, batch reviews, laboratory and manufacturing oversight.Authoring of policies, procedures, training programs. Technical and business writing, editing, and proofreading: Proposals, quality agreements, standard operating procedures (SOPs), p...

Consultant for Oral Drug Delivery Dosage Forms with Controlled Release and Sustained ReleaseOral solid dosage form formulation and process development.Drug delivery technology for controlled release dosage forms (osmotic, matrix and multiparticulates) and enhancing the oral bioavailability of poorly soluble compounds.Controlled release and sustained release drug dosage forms.Spray dried and hot melt extruded dispersions.Development and application of drug delivery technology.Extensive experience in formulation and process development for controlled and sustained release formulations and poorly soluble compounds for oral delivery.Osmotic sy...

Aerosol Expert for Performance Studies and Regulatory Agency Compliance, Including Quality Assurance of OTC Drug Products.Aerosol issues (troubleshooting, clogs, leaks, failures) and aerosol performance studies.Quality assurance, control and regulatory with experience in manufacturing OTC drug products.Communication and compliance with FDA, EPA, CARB.Developing new systems capable of tracking location and status of all components, raw materials, and finished goods while product is in operation.Undisclosed Company, Quali...

Life Sciences Expert Specializing in Finance and ValuationLife science professional with scientific research experience and financial expertise.Biotech and business development, deal making, commercialization of highly specialized products, strategy, analysis and client interface.Focused AreasValuationDue diligenceNegotiationStem cellsFinancial modelingFinancial analysisCommercializationTechnology transferMarket penetrationBiotechnologyCleantechCancer cell biologySarcomaUndisclosed Company, Associate Director, 2010 - PresentProvide financial advisory services to clients looking to g...

Synthetic Drug Product Development Expert - Marketing and IP Management, Including Qualification of Drug Product Manufacturers and Preparation of Regulatory FilingsMore than 30 years leadership in the pharmaceutical and chemical industry.New compounds and discoveries in chemical processes.Expertise in the chemistry of vitamin D and analogs, anti-infectives (macrolides, quinolones, HIV protease inhibitors), taxanes, peptidomimetics, and other anticancer drugs, steroids, prostaglandins and cannabinoids.

Pharmaceutical Molecular Modeling Expert in Ligand-Based and Structure-Based Design, and Structural Bioinformatics. Pharmacophore Modeling for Muscarinic AgonistsMolecular modeler in ligand-based and structure-based design, including structural bioinformatics.Provide scientific content for the protein folding and 3D drug design modules.Establish criteria for compounds through CADD/NMR (Computer-Aided Design and Drafting/Nuclear Magnetic Resonance Spectroscopy).Pharmacophore modeling for muscarinic agonists that was developed through phase II clinical trials.

Extensive Knowledge of Neurological and Psychiatric Disorders expert specializing in preclinical basic and applied CNS drug discovery researchPreclinical CNS research: Preclinical basic and applied CNS drug discovery research in the international pharmaceutical industry.A Neuropharmacologist and an accomplished drug hunter, with in-depth knowledge and broad expertise at the world's largest drug company.In-vitro neuropharmacology identifying new compounds in drug development and establishing new assay enhancements.Extensive preclinical evaluations for the advancement of drug candidates.Extensive knowledge of neurological and psychiatric di...

Pharmaceutical Technical Operations Executive Specializing in Drug Development and OperationsPharmaceutical chemistry manufacturing and control.Small virtual pharmaceutical manufacturing.Materials management and control.Pharmaceutical quality assurance.Technical services.Undisclosed Company, Managing Principal, 2010 - PresentProvide service to virtual pharmaceutical and biotechnology industry in the areas of supply chain, manufacturing, project management, quality and compliance.ProjectsLed CMC development team for a Phase I/II small molecule progr...

5 - Meta Description Formulation Development and Manufacturing Technology Expert of Pharmaceuticals, Nutraceuticals and Cosmetics Multiple Delivery Platforms. Extensive Experience Working with FDA, DEA (U.S.A.) EMEA, EFSA (Europe), TGA (Australia), NHPD, and HPFBI(Canada).Formulation development and manufacturing technology of pharmaceuticals, nutraceuticals and cosmetics on any delivery platform.Analytical oriented work in solids, liquids, topical and sterile products, over the counter - OTC, non-prescription medicines, vitamins, and nutritional products.Development and manufacturing management with focus on dietary supplements, respira...

Consultant in, and Drug Delivery for Oral, Topical, Rectal, Vaginal and Parenteral Products Covering all Stages of Development from Preformulation through to Technical Transfer into Commercial Production, and Expert Witness.Pharmaceutical formulation scienceDrug deliveryPharmaceutical excipientsPharmaceutical quality by designPharmaceutical preformulationScale-upTechnical transferSolid oral dosage formsLiquid dosage formsSemisolid dosage formsPoorly soluble drugsChemistry, manufacturing and controls documentationChemistry, manufacturing and controls project managementTrainingExpert Witness ExperiencePatent infringement, controlled release...