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...

Drug Discovery and Specialty in Small Molecules, Radiopharmaceuticals, Pre and Post IND PharmaceuticalsDeep understanding of pharmaceutical and biotech industries acquired over 33 years.Oncology, infectious diseases, arthritis and other inflammatory and immune diseases, respiratory disorders and acute and chronic pain.Small molecules, including radiopharmaceuticals, for therapeutic and diagnostic/imaging applications.Pre- and post-IND drug development experience, including translational medicine.Technology platform enhancement and innovation (in-house and in-licensed).Significant business development and strategic planning experience.Exten...

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...

Bioengineering Consultant with Expertise in Parental Products, Vaccine Production, Protein Purification (Recombinant Protein), Scale up - Downstream Processes, CMC, IND and IMPDPharmaceutical drug development, regulatory affairs, and commercial manufacturing of biologics and combination products.Recombinant proteins of different classes, vaccines, plasmids, small molecules, and combination products involving controlled release formulations.Preform scale up of downstream processes.Development and optimization of protein purification in the recombinant protein production.Regulatory requirements for biopharmaceutical development and manufactu...

Accomplished chemist and regulatory professional for Pharmaceutical and Biotechnology industries. Pharmaceutical Development Services, CMC and Analytical Chemistry, QC, INDs/NDAsAccomplished chemist and regulatory professional with over 25 years' experience in Pharmaceutical and Biotechnology industries.CMC (Chemistry, Manufacturing and Controls), analytical chemistry and drug development of small molecules, proteins and biologics (cells, viruses, plasmids).CMC programs for oral, inhaled, topical and parenteral dosage forms.Technical and program-level supervision of formulation, analytical and manufacturing in support of product-manufactur...

Global Pharmaceutical Creation and Implementation of Systems to Increase Efficiency, Sustain Regulatory Compliance, Interpretation of Regulatory Requirements: Quality Systems, cGMP, Good Laboratory Practices, IND/NDA/ ANDA/ DMF and CAPAGlobal market place creation and support; implementing systems, increase efficiency and sustain regulatory compliance in the pharmaceutical industries.In-depth knowledge and interpretation of regulatory requirements as applied to quality systems, cGMP, Good Laboratory Practices, laboratory equipment expertise.Vendor assurance programs, stability programs, validation (equipment, process, and analytical), manu...

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...

Transitional Medicine-Protein Therapeutics and Nanobiotechnology Focusing Alzheimer’s, Brain Trauma & Cancer Through Drug Development, Nanoparticle based targeted-drug delivery of chemotherapeutics an  Recombinant antibodies (scFv, Fab), immunotoxins and antibody-drug conjugates (ADC), targeting characterization and pre-clinical testing in animal models. Expression, purification and characterization of biotherapeutics and testing in cancer xenografts in mice. Combinatorial phage library screening in disease models of cancer, brain diseases (Alzheimer’s, Traumatic Brain Injury) and drug-resistant bacterial infections. Transit...

Global Ph.D. Biopharmaceutical Analyst Expert: Lean Manufacturing, Program Management, Validation and QualificationCreating lean analytical departments with significantly improved efficiency and turn-around-times. Organizational effectiveness and culture improvementStrategy and execution for concurrent large-scale projects.Biologics (large molecules); small molecule development and analytical development.Research and development executive management; project program management and validation and qualification.CAPA; investigations; drug product development and transformational leadership.CMC expertise: IND, BLA, NDA, 510K, PMA, ANDA, qu...

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...