Specialist in pharmaceutical research and development, synthesis and scale up of experiments, anti-cancer drugsBiotechnology and pharmaceutical research and development:Pharmaceutical process research and process development.Multi step organic drug synthesis: Route and reagent selections; literature and patent survey of synthetic routes; synthesis of API or API intermediate to ensure non infringing routes.Skilled at the use of Boron reagents.Drug discovery:Strategies for discovery of new Inotropic agents (synthesis of modified Adenosine Monophosphate) for heart failure.Discovery for synthesis of novel prodrug oligonucleotide for Cytarabi...

Drug Analytical Support Consultant with CMC and Consent Decree ExpertiseAssessing specification and CMC analytical development for pharmaceutical drug substances and drug products.Analytical project planning and strategies for early, mid and late stage development programs.Writing, editing, and reviewing analytical technical reports.CMC and regulatory submission documents for Health Authority and FDA responses.HPLC method development, validation and transfer.Subject matter expert for the isolation and identification of synthetic impurities and degradation product unknowns.Contract Research Organization (CRO) management.Analytical Investiga...

Consultant for Medical Device Validation and Blood Bank Operations and Collection Devices per FDA RegulationMedical device submissions, regulatory affairs related to medical devices and pharmaceutical, good manufacturing practices (GMP) and Quality Systems Regulation (QSR).FDA compliance procedures including process validation, product validation, software validation, warning letters, consent decree resolution, compliance audits, supplier audits and ISO registrations.Extensive and broad knowledge of U.S. FDA quality and regulatory body regulations.Specializing in medical device submissions, regulatory affairs, and Good Manufacturing Prac...

Energy and Power Plant Expert for Combustion Turbine Plants, Nuclear Plants, Petrochemical Power Plants, Coal Plants, and Boiler Islands.Environmental project and permitting management for electrical power plants.Design, construction, and startup or electric and petrochemical power plants.Combined cycle project development.Integrated gasification technology development.Clean air act and multi-pollutant compliance project implementation.Power plant betterment/life extension project implementation.Chemical plant/power plant startup and commissioning.

Aerosol Expert for Performance Studies and Regulatory Agency Compliance, Including Quality Assurance of OTC Drug Products.Aerosol issues (troubleshooting, clogs, leaks, failures) and aerosol performance studies.Quality assurance, control and regulatory with experience in manufacturing OTC drug products.Communication and compliance with FDA, EPA, CARB.Developing new systems capable of tracking location and status of all components, raw materials, and finished goods while product is in operation.Undisclosed Company, Quali...

Medical Device Consultant (In-Vitro Diagnostics - ISO 13485, 510k, De Novo, CE, CFR 820) with International Experience in Consulting, Program/Project Management, and Manufacturing510k submissions in medical devices.New business and PMP skills managing multiple international projects.Technical proficiencies and strategic planning to optimize existing products and develop new IVD assays.Risk management: Providing risk management assessments, FMEA - design and process, and developing risk management protocols.Composing and documenting product requirements specific to FDA, CLSI, ISO and CE regulations.Technology transfer.Regulatory activities...

Occupational and Industrial Toxicology Expert: Program Development, R&D and Product Safety Working in the Biotechnology, Medical Device and Pharmaceutical IndustriesOccupational and industrial toxicology, development programs (both preclinical and clinical) and study design.Conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies.Addressing commercial concerns, and contract research organizations in labeling and other FDA compliance issues for drugs, devices and dietary supplements.Identifying, developing and implementing new...

Recombinant DNA E. Coli Fermentation Development Expert Specializing In Fermentation, Scale-Up, Technical Transfer and ValidationDevelopment of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Scale up of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Technical transfer of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Validation of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.

Fermentation Expert in Compliance Activities, FDA API Manufacturing (US and European sites) Commercialization, FSMA PCQ1 trainer, Development of Procedures Laboratory Methodology and TrainingRegulatory support for organizations dealing with new product approvals and introduction, expanding operations, technology transfer, and changing customer, regulatory or certification requirements.FSMA (Food Safety Modernization Act) compliance in regulatory analysis, strategies and meeting deadlines.FSPCA Lead Instructor (Human Foods Certified and Animal Foods Certified), providing PCQI training to industry and regulatory agencies, including FDA.Preve...

Medical Device Consultant Specializing in Materials, Design, Test Method Development, Product Development, Quality System Regulations, Process Validation, Supplier Qualification, ISO, FDA and REACH Compliance. Medical Device Process Validation Consultant, Supplier Qualification, ISO, FDA and REACH compliance.Product development from concept to market.21CFR820 (cGMP) and ISO13485 QSR.Polymers and materials for medical devices.Vascular and catheter systems.DOEs and process optimization.Process Validation (IQ, OQ, PQ).Medical device design control process.EPA, FDA, REACH and RoHS compliance regulations.Fluoropolymer and lubricious coating com...