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...

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...

Pharmacist Specializing in Asia/ India Specific Regulatory Requirements - Marketing Authorization, Clinical Trial Permission in Biologicals and Other Market Research; Pilot Plant and Pharmaceutical AnalysisDiverse experience in pharmaceutical regulatory affairs at national and international levels.Current pharmaceutical regulations in India with major regulatory authorities.Acquired training in international forums by (WHO), World Health Organization and USFDA.Working at apex drug regulatory body in India.Inspection of clinical trials.Sourcing pharmaceutical Information.

PhD in Immunology focusing on pre-clinical research and clinical translation. Small Pharmaceutical Business Development and FDA-IND FilingMolecular aspects of neuro-oncology.Extensive tumor immunology and neuro-oncology laboratory experience.Developmental use of clinical samples for molecular and immunological studies.Small animal stereotactic surgery, tumor modeling and drug delivery techniques.Clinical research translational development.FDA interaction, IND writing and development.Patent development.Grant development.Small business (pharmaceutical spin-off) development and management.

National-International Therapeutic Expert Focused on Inflammation/Autoimmune Disease, Transplantation, Respiratory Diseases, Infectious Diseases, Vaccines, Diagnostics, and Oncology.Strategy and streamlined processes for the identification and evaluation of strategic partnerships.Ability to obtain alignment, prioritize and build consensus from internal stakeholders.Diverse therapeutic area expertise in both global and U.S. markets, including; inflammation/autoimmune disease, transplantation, respiratory diseases, infectious diseases, vaccines, diagnostics, and oncology.Academic collaborations, technologies, early and late stage products, p...

Executive Pharmaceutical Research Physician (MD, PhD) Consultant experienced in Clinical Research (Phase 2-4), Regulatory Affairs (inc. filings), Program Strategy Development, Medical Affairs, Advertising and Promotion, Medical Education, Life-Cycle Management and Launch Activities.Review of digital and non-digital Advertising and Promotion materials for existing brands, as well as new product launches, (U.S. and international) press releases, educational materials, sales rep training, OPDP, (Office of Prescription Drug Promotion) regulations.Life-cycle management and new product launch activities, including:Advisory boards, KOL developmen...

Pharmaceutical, Biotech, Diagnostics and Drug Discover, Commercial Development and Medical Device ProfessionalProduct development programs and projects.Analyze markets, align technology solutions with healthcare market needs, develop insights and business strategy for future customer needs.Develop initiatives programs and drive action plans.Defining and executing winning strategies for successful business growth through deployment of strategic directions, risk management and operational excellence techniques.Pharmaceutical, biotech, diagnostic,and drug discovery.CROs, and medical device markets working within matrix team(s) to identify op...

Senior Pharmaceutical Professional Specializing in Global Business Development in the Healthcare Industry Focused on: Medical Devices, Drug Development, Regulatory Affairs, Quality, cGMP, FDA, Pharmaceutical and Clinical ResearchSenior Pharmaceutical Executive concentrating in medical devices, and the pharmaceutical research industries.Global pharmaceutical business development.Regulatory affairs, quality control, clinical research industries and operations.Submission preparation: IND, CTD, ANDA, NDA and MAA.Clinical research including protocol and medical writing.Strategic planning and business analysis.New pharmaceutical development and...

Senior Pharma Regulatory Consultant with Expertise in Strategic Planning, Development, US Regulatory Preparation, Documentation (IND ANDA, DMF, CTD) and Quality AssuranceExpediting pharmaceutical services in: Pharmaceutical regulatory, Quality Assurance (QA), global pharmaceutical support, investigational and drug development.Enhancement and development of regulatory affairs with an overall development of regulatory strategy for business models through evaluation and control of pipeline products for commercial and drug development venture companies.Building pharmaceutical regulatory departments and assessing their effectiveness in paralle...

PhD Biostatistician with expertise in Regulatory (FAD and EMA activity), Data - Safety Monitoring in the Pharmaceutical and Medical Device Industries. Scientific Advisory Participant.Biotechnology FDA and EMA submission in the pharmaceutical and medical device industries.Biostatical litigation specific to pharmaceutical and medical devices.Pre- and Nonclinical, Phases I - IV in biostatistics, data management, statistical programming, and etechnology across various therapeutic areas.Analysis of over 420 clinical studies, with over 30 in Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE).Build effective innovative an...