Ph.D. Organic Chemistry Consultant with Expertise in Drug Discovery and Early Development in Pharma and Biotech Industries. Infectious Diseases, Immunology, Oncology, CNS and Metabolic Diseases.Drug Discovery and Development Leader in the pharmaceutical and biotechnical Industries.Deliver candidates into clinical development with focus on infectious diseases, immunology, oncology, CNS and metabolic diseases.Raising venture capital and non-dilutive funding.CRO and CMO landscape Program Manager, setting up partnerships and collaborations.Execute complex research programs in a virtual environment.Project management, timelines and budgeting.Me...

PhD with expertise in Pharmaceutical Assessments, Investigations, 3rd party certifier, and Regulatory; FDA EMA, MHRAOver 33 years' experience in quality, microbiology and regulatory affairs.Pharmaceutical assessments, prioritization, establishment of realistic timelines for the implementation of consent decree commitments and 3rd party certifier of deviations-investigations.Ensure the robustness of quality systems - change control, product complaint handling, revision of SOPs, and control of 3rd parties.Quality assessment of sterile injectable, small molecules and biological as well as other dosage forms.Solid and liquid oral dosage forms...

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...

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...

Expert for Personal Care Products, Skin Care and Cosmetic FormulationsSynthesis chemistry for personal care products.Expert in product applications in the personal care industry such as body lotions, deodorants, hand bactericides and sunscreens.Extensive knowledge of chemistry, formulations and use of antiperspirants, deodorants, lotions, silicones, esters, emollients, moisturizers and controlled release personal care products.Understanding of back-label regulations and how to establish INC names.Understands the connection between technology and commercial opportunity for success in personal care cosmetic industry.Expert witness for patent...

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-...

Organic Medicinal Chemist with Expertise in the Synthesis and Design of Medicinal Drug CandidatesMedicinal Chemist with a proven track record of success in the synthesis and design of medicinal drug candidates.Provide creative and innovative solutions to chemistry challenges including the safe design, conduct, interpretation and technical evaluation.Significant synthetic research experience in multi-step milligram to multigram quantities of intermediates and products, diversity design, crystallographic modeling and experience with protein-protein interactions.Molecule design in partnership with pharmacology and moving projects forward in a...

Pharmaceutical Dosage Form Process Engineer: Spray Congealing, Spray Drying, Fluid Bed Coating and Fluid Bed GranulationPharmaceutical process and product development.Design and development of unusual and novel pharmaceutical processes and dosage forms.Extensive experience from initial process development to commercialization.Process evaluation - process design, develop, scale-up, robustness, troubleshooting.Mass Transport and unit operations.Extensive experience in unit operations in pharmaceutical processing development to commercialization:GranulationCompressionExtrusion (melt extrusion and continuous granulation)Spray congealingSpray...

Pharmacokinetics Consultant Specializing in Drug Metabolism, Drug Discovery and Early Drug Development.ADME, (Absorption, Distribution, Metabolism, and Excretion) and PK (Pharmacokinetics) in drug discovery.Early drug development.In vivo and in vitro enzyme induction.Cytochrome P450 enzyme inhibition and potential for drug-drug interaction.In vitro and in vivo metabolism and metabolite profiling.Preclinical studies to evaluate ADME, toxicokinetics, and PK profile of drug candidates.Due diligence to evaluate DMPK profile of drug candidates for potential purchasing or in-licensing opportunities.Interaction with CROs for contracting and monit...

Pharmaceutical Formulation Development and Process Development ScientistPharmaceutical formulation development and process transfer, serving over twenty five years' in the pharmaceutical industry.Develop products; solid dosages, liquids, capsules, research new technologies, and sustained release technologies.Experience with formulation, validation and scale up of all the above named disciplines.Supervisor and Manager responsible for staff consisting of formulators, packaging engineers, and equipment engineers.Clinical supply manufacturing and troubleshooting processes with successful transfer to process engineering and then to manufacturin...