Occupational and Industrial Toxicology Expert: Program Development, R&D and Product Safety Working in the Biotechnology, Medical Device and Pharmaceutical IndustriesOccupational and industrial toxicology, development programs (both preclinical and clinical) and study design.Conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies.Addressing commercial concerns, and contract research organizations in labeling and other FDA compliance issues for drugs, devices and dietary supplements.Identifying, developing and implementing new...

International Immunology and Virology Ph.D. Specializing in Genetics, Molecular Hematology, DNA and Dementia DisordersRare genetic diseases.Gene therapy.Stem cell.Molecular biology diagnostics.Immunology and virology diagnostics, development and basic research.Genetic analysis in human biological samples, (amniotic fluid, chorionic villus blood, bone marrow, buccal swab and DNA samples).Molecular hematology, blood, bone marrow, buccal swab and DNA samples and genetic analysis.Investigation of genetic causes of dementia disorders.Genetic plant analysis, plant material, seed, food, and feed.Educator and examiner within pharmacology, pharmacy...

Drug Therapeutic Discovery Medicinal Chemist Consultant: Pain, Inflammation, Cardiometabolic, Oncology and AntimicrobialsHit generation, lead identification, and lead optimization. Strategies, implementation plans and problem solving.Drug Discovery - "Concept to Clinic" - Road map and expectations. Goal setting, testing schemes, progression path tracking.Intellectual Property - Assessment, strategies and management. Due diligence on prior art, patentability. Expert witnessDrug discovery across therapeutic areas - Pain, inflammation, cardiovascular, metabolic, oncology and antimicrobial therapeutics.PK/PD (Pharmacokinetic and Pharmacodynam...

Design and Synthesize Drug Candidates for Discovery and Development: Chiral, Polycyclic, 3-8 Step Synthesis for Cancer, CNS, Pain, Diabetes, Microbial Infection, AIDS). Design and Synthesize Diagnostic Reagents and In Vivo Imaging Agents - Macrocycles, Antigens, Polycyclic Heterocycles.Synthetic and discovery organic chemistry for the pharmaceutical industries with applications in CNS, cancer, and pain.Preclinical development chemistry for pharmaceutical scale-up, metabolites, impurities, and deuterated drug candidates.Synthetic organic chemistry for in-vitro and in vivo diagnostics, including antigens and biotin conjugates with varied r...

Expert in Identification and Optimization of Pharmaceuticals, Drug Discovery, Profile Development (Central Nervous System-Non CNS Drugs), Therapeutic Drugs, Pharmacophore ModelingScientific research and management records for the pharmaceutical industry:Inventor of a preferred method in the industry for LogP calculation3D-QSAR methodPharmacophore modelingA quantitative definition of drug like moleculesPotent anticancer compounds.Provide computational chemistry and chem- and bio- informatics problem solving for drug discovery.Computer aided drug discovery: Developed and led computational chemistry, cheminformatic laboratories in industrial...

Regulatory Pharmaceutical Compliance Consultant with Expertise in Clinical, Pharmacovigilance, Biologics, Biosimilars, Orphan Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic, and Food.Regulatory strategy, pathways and gap analyses.Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, a...

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...

Veterinary Pharmacology and Pharmacokinetics, Bibliographic Assistance, Tissue Residues and Product RegistrationPharmacokinetics in domestic animals.Tissue residues of veterinary drugs.Milk residues of veterinary drugs.Pharmaco-toxicological monographs for veterinary drugs.Registration and development of veterinary pharmaceuticals.Expert-Pharmaceutical RegistrationTechnical support for the development and registration of more than 200 pharmaceutical products for veterinary use in Argentina and Latin America.Independent Consultant...

Ph.D. with expertise in Drug Metabolism and Pharmacokinetics, Pharmacodynamics, and Toxicokinetics. Investigational New Drug approval experience in USA and ChinaDMPK (Drug Metabolism and Pharmacokinetics), PD (Pharmacodynamics), TK (Toxicokinetics), Toxicology, and Safety fields.Oversight of outsourced GLP studies and in-house non-GLP studies for candidate drugs in oncology, inflammation, anti-virus, and hypertension fields.IND (Investigational New Drug) approval both in U.S.A. and China, as well as 15 years of experience in small molecular novel drug discovery and development, and 20 years of experience in drug metabolizing genes/enzymes...

Medicinal Chemist Specializing in the Design and Synthesis of Antibacterials and other Antiinfectives. Drug Development and Project Management from idea to Clinical Trials.Antibacterial chemotherapy including beta-lactams, quinolones, DNA - gyrase and top IV inhibitors, peptide antibacterials, pleuromutilins, glycopeptides, oxazolidinones, 2-component signaling, natural products, single enzyme targets such as the Fab and Mur proteins, GlmU, LpxC, and mechanism based small molecule inhibitors projects.Antiviral chemotherapy: HIV and Herpes antivirals, HIV protease, HIV integrase, HIV-NCp7 (nucleocapsid protein).All aspects of medicinal che...