Regulatory, R&D, and Manufacturing Experts for the Path Forward
Who We Are
Edaphy caters to the life sciences industry by offering regulatory expertise, product and process development, manufacturing, quality management, and more. Our team of experienced professionals includes entrepreneurs, medical doctors, scientists, researchers, lawyers, and regulatory experts.
Some of our Subject Matter Experts
Andy Mattai, MD — Regulatory Strategy, Research Implementation, and FDA Engagement
Board certified in Psychiatry, Dr. Mattai pursued a clinical research fellowship at the National Institutes of Mental Health, was a Medical Officer at the FDA Center for Drug Evaluation and Research, and Medical Director at Vanda Pharmaceuticals. Summa cum laude graduate of Knox College and Iowa Carver College of Medicine.
Mark Morrison — Medical Device Development
Over 40 years of experience at West Pharmaceutical, Teva, i-STAT, and Philips Healthcare. Full product life cycles for medical devices and drug-device combination products, including engineering, reliability analysis, manufacturing, and intellectual property protection.
Knowledge of product development processes designed to meet regulatory guidelines such as FDA 21 CFR Part 820 and Part 4, IEC 60601, ISO 13485, ISO 14971, etc. Deep experience with inhalation, respiratory, and parenteral drug delivery technologies. B.S. from Cornell in Electrical Engineering.
Ben Taylor — Software and Cybersecurity
Ben is a seasoned professional with 30 years of experience in the pharmaceutical industry, focusing primarily on the commercialization of specialty pharmaceuticals. He has a proven track record of leading successful commercialization initiatives for companies such as Pfizer, Forest Laboratories, Trius Therapeutics, Tetraphase Pharmaceuticals, and scPharmaceuticals. Areas of expertise include pharmaceutical commercialization, sales operations, and data management.
Marnie Junker — Quality Management
Marnie has over 30 years of experience of Quality and Compliance in Pharmaceuticals, Medical Device, Nutraceuticals, and food manufacturing and contract manufacturing industries at Stryker, Perrigo, Omni Quality Assurance, etc. Expert in Audit Management, responses, gap analysis, responses, deviation investigations, and CAPA’s. Excellence in continuous improvement activities, lean manufacturing, project management, communication, innovation, technical writing, training, and collaboration skills. Certifications include: HACCP, PCQI, Certified Quality Auditor Certificate (CQA).
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