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Fermentation, Scientific and Regulatory Affairs
Expert is dedicated to commercializing novel ingredients for health and sustainability Proficient in human pathology, plant biology, synthetic biology, and fermentation technology. Her specialties include Product Innovation and Formulation, CPG Application Testing COGS and Process Improvement, Food Science, Safety and…
Scientific, Clinical, Medical, and Regulatory Affairs
Expert is a senior executive and a global biomedical leader with expertise in all facets of basic, pre-clinical, clinical research, and regulatory science for drug, biologic, therapy, vaccine, and medical device development. Expert is a leader in strategic planning and…
Product Compliance, Regulatory Affairs, Safety EMI EMC, ENV, RoHS Testing and Certifications
Have eight years of experience in product compliance testing and certification—hands-on experience on Product Safety, EMI EMC & Environmental standards. • Good Knowledge of various national & International standards. • Experience in dealing with the CE, TEC, BIS, UL, CSA,…
Medical Devices, Business Development, Regulatory Affairs, Project Management
Expert successfully launched over 25 new instrument and disposable medical devices. He developed and managed numerous cross-functional and cross-cultural new product and process teams. He has developed rich experience in team leadership and assembly, grounded in RA/QA fundamentals (RAC Certified).…
Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Drug Discovery & Development, Preclinical Safety Assessment: Toxicology, Pathology & Regulatory affairs
ExpertS. Expert has over 33 years of experience in safety evaluation- Toxicology & Pathology – histopathology slides evaluation, Regulatory, drug discovery & development research, having worked in Switzerland, UK, Sweden and India. He has experience both in the pharmaceutical Industry…
Software – Quality Assurance, Regulatory Affairs and Licensing
Expert has over 25 years experience of delivering software solutions/applications to healthcare industries, including R&D, Manufacture and point-of-care delivery (e.g. hospitals). This includes negotiating the difficult areas of licensing in Europe, the USA and beyond, accreditation and certification to ISO…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…