Pharmaceutical Regulatory Strategy Assessment, Development and Execution for Novel Therapeutics, Interactions with Regulatory Authorities and Regulatory Due DiligenceStrategic regulatory aspects of the development of novel therapeutics encompassing initial registration - approval and life-cycle management of multiple pharmaceuticals (in multiple therapeutic areas).Planning and execution of interactions with regulatory authorities (esp. US FDA).Regulatory due diligence review and appraisal of therapeutic development programs, regulatory aspects in the development of a pharmaceutical for the legal defense.Regulatory due diligence input on po...

Medical Device Risk Management, Quality Systems Management, Supplier Qualification and Quality Assurance: In Vitro Diagnostic Medical Devices (Class II), Biotech Manufacturing Operations, Digital Imaging Equipment, and Interventional Devices (Class III), Bio-based MaterialsMedical device and biomedical industry planning, Integration, and organizational improvements, increasing financial performances for U.S. and European businesses.Aligning technology and business strategy, medical device quality management regulations and requirements into effective and useful management systems.Remedial quality management system compliance.Pre-certifica...

Pharmaceutical API and QA Consultant with Expertise in Steroids and Norsteroids Manufacturing. Lean Management, Validation, FDA InspectionsActive Pharmaceutical Ingredient (API) manufacturing and quality assurance, successful scale-up, technology transfer and quality assurance projects.Steroid plant operations; training, FDA inspections, and manufacturing.Lean management in API manufacturing.Quality assurance management; release operations in packaging processesAPI manufacturing - steroids and norsteroids.Pharmaceutical products scale-ups and technology transfers.Qualification of equipment (reactors, centrifuge, dryers etc.) and utilities,...

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...

Intellectual Property and Regulatory Consultant Specializing in Patents on and FDA Regulation of Novel Medical Device and Biotech DevicesIntellectual property (IP) and regulatory strategy.FDA regulation of novel products such as wearable medical devices, and electronic cigarettes.Patent protection of drugs, medical devices, dietary supplements, and tobacco products.Patent landscaping and freedom-to-operate analyses.Consultation with and representation before U.S. Food and Drug Administration (FDA).IP and regulation surrounding novel technologies such as RNAi, gene editing, and synthetic biology.In vitro diagnostic medical device and consu...

Ph.D. Expert Developing Immunology and Molecular Assays, Due Diligence, Gene Editing, RNAi, Automated Cloning, CRO, CMO and IND SubmissionsAssessments and due diligence for funding of synthetic biology companies. Mentor to start-ups within the Biological portfolio to attain seed and series funding.Synthetic biology, specialty chemicals, and nutraceutical products.Develop and execute cell-based, immuno, and molecular assays for release of large molecule therapeutics.Development of assays for large molecule therapeutics from multiple modalities including monoclonal antibodies, antibody-drug conjugates (ADC), T-cell engagers, and small pept...

Regulatory Affairs Consultant for Medical Devices: Expert in U.S. and Canadian Medical Device Approval ProcessSummaryTwenty plus years working in the medical industry in the areas of regulatory affairs, quality assurance, clinical studies, research and development, test, manufacturing and technical service.Regulatory affairs consultant servicing worldwide providing clients with compliance, submissions and training services to the medical device and IVD Industries.Regulatory ExperienceExpert knowledge of U.S. FDA, Health Canada and the European Medical Devices Directive regulations.Product approval and clearance submissions such as 510(k)s...

FDA Regulatory Affairs and Labeling Expert for Food, Cosmetics, OTC Drugs, Pet foods, and Medical DevicesFood and Drug Administration Regulations (FDA), in foods, dietary supplements, cosmetics, OTC drugs, pet foods and medical devices.Knowledge of allowable marketing claims for FDA regulated consumer products.Research and consumer health product development.Nutrition evaluation of food products.Product formulation and marketing.Undisclosed Company, Owner and Principal, 2001 - PresentProviding clients with over 20 years' experience in b...

Experienced Senior Scientist Obtains Proven Track Record in Research and Product Development, Support, Validation. Clinical Assay Development, Medical Devices, Planning- Executing 510(k) Applications.Summary Experienced Senior Scientist with a proven track record in research and product development/ support/ validation. Clinical Chemistry Expert; polymer chemistry, assay development, medical devices, fluorescence, planning and executing 510(k) studies, writing and editing 510(k) applications. Subject matter expert for chemistry and test method validation on behalf of clients’ companies. Numerous processes validation during compli...

Specialty Chemicals & Pharmaceutical Supply Chain-Change Agent, Regulatory, EPA, OSHA-PSM and Global Manufacturing ExpertPharmaceutical and specialty chemical operations with 20 years’ in supply chain Leadership for large facilities, providing technical solutions in challenging environments in union and non-union members. Manufacturing and operations professional, action-oriented, building effective teams and delivering positive results with unlimited drive for continuous improvement in fast paced, global businesses. Change agent and transformative leader in global manufacturing footprints leading to increased efficiency and throughp...