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...

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...

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...

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...

Organic Chemist in Pharmaceutical Development and Quality Compliance, with Biopharmaceutical and Medical Device DevelopmentPharmaceutical development and quality compliance.Biopharmaceutical and medical device development.Development of pharmaceutical activates related to controlled release drug elute stent medical devices.Contract Service Provider (CRO) management.API development, vendor selection and CMC submission.Bioanalytical method development, validation and testing.Regulatory requirements and compliance, identify pathway, development strategy, define scope and preform gap analysis.Regulatory submissions and preparations (IND, amen...

Ph.D. Cellular & Molecular Medicine Consultant with Expertise in Pharmaceutical Development, DNA and RNA Sequencing, Translational Research and Clinical Trial Development SpecialistPreclinical pharmaceutical development and therapeutic analysis in rodents.Investor due diligence of preclinical data.Cancer genetics, genomics, epigenetics, and epigenomes.Bioinformatics.Genetically engineered and transplantable animal models of disease.High throughput and next generation DNA and RNA sequencing.Genome engineering using CRISPR.Molecular biology and pharmacology.Biomarker development and testing.