Expert Directory
Having an expert witness or consultant at your side can help you navigate complex situations with confidence. These professionals understand your industry and excel at conveying crucial information, whether in a courtroom or a consulting environment. At Intellex, we have experts in over 30,000 areas in our database. We enable you to partner with an individual who has the knowledge, educational background, and relevant experience to support your needs effectively.
Utilize our expert finder tool to handpick the ideal mentor or consultant for your specific application.
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
Nanotechnology Regulatory, Environmental, Health, and Safety Issues
Expert has applied his chemical engineering education to the field of nanotechnology by providing regulatory compliance assistance to companies manufacturing and using nanoscale materials. His knowledge and experience with Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide and Rodenticide…
Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Food Technology & Processing Consultant
Expert has a great deal of experience in testing the imported and locally produced canned food products during his work as the head of food laboratories in Jordan Food and Drug Administration. Over six years, he has developed reliable experience…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section…
Pharmaceutical Marketing and Litigation, Major Pharmaceutical Trends, International Business
Expert has been a Vice President, Marketing for two major pharmaceutical companies, most recently Pfizer, overseeing sales of $600 million. He has twenty years of experience in pharmaceutical marketing Expert was a Managing Director for the Nordic region in Europe…
Food Service Management and Institutional Kitchen Design, Food Safety, Food Service Training, Food Operations Review, Retail Foods, FDA
His expertise in business management is related to the management of food service operations and systems. He uses his thirty five years of managing multi-unit food service facilities and his experience teaching Food Organization and Management, a upper division class…
FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action…