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Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as provided re-engineering support for out…
Baby Diapers, Non-Woven, Absorbent Products, Films, Wipes, and Consumer Tissue & Towel
Has extensive experience in the development and evaluation of absorbent materials of all types for the management of all types of human exudates. This includes cellulose absorbent cores, superabsorbent materials, foams, fibers and non-woven absorbent materials. Has commercialized over a…
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,…
Medical/Surgical Device Design, Management, Marketing, Regulatory
Expert is a results-oriented professional with proven domestic and international experience in health care administration, medical devices, marketing, staff development, product development and management, luminary and customer liaison, public relations, technology assessment and transfer, intellectual property, research and development, clinical…
Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP’s/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international regulatory inspections (USFDA…
Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…
Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
As the former CIO of a Fortune 50 product development and commercialization subsidiary, and the executive tasked with building an ISO compliant records management program, Expert has had more than 15 years of experience planning, developing, implementing and then managing…
Business Development and Expansion
Expert has over 30 years of progressive business experience, including small businesses to multinational organizations, and has been intimately involved in Marketing, Human Resources, Training and Development, Operations, and Finance. His experience is well rounded and balanced, and he has…
Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Medical Device, Diagnostic, and Pharmaceutical Clinical Trial Design and Strategy
Expert has over 25 years experience in commercializing medical products. Her experience includes management at Abbott Labs in clinical research and regulatory affairs and as a CEO of a venture capital backed medical diagnotic company. Expert has raised venture money…