Dr. Karin A. Kook

Karin A. Kook, Ph.D.Managing Director

Karin A. Kook, Ph.D., Managing Director, Salamandra LLC.Dr. Kook founded Salamandra LLC in1996.Dr. Kook and her colleagues at Salamandra provide strategic, technical and regulatory consulting services to the pharmaceutical industry for drug, biologic and device development.Dr. Kook's work for client firms has spanned all facets of product development, from the early stages of screening and evaluation, to formulation of strategic business plans and the preparation and production of a wide range of regulatory submissions.These include Investigational New Drug application (IND) and Investigational Device Exemption (IDE) preparation; premarket notification [510(k)]; clinical development plans; New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA) and Premarket Approval (PMA) application preparation; and preparation for FDA meetings and advisory committees.Dr. Kook's primary areas of technical expertise are in the clinical and regulatory aspects of product development, gained over the past 20 years working at the FDA, the pharmaceutical industry, and as a consultant.Dr. Kook served 6 years at the FDA where she was a medical reviewer in the Center for Drug Evaluation and Research (CDER); her primary dutieswere clinical review and evaluation of applications for psychopharmacologic drug products.Prior to that, Dr. Kook was a clinical pharmacologist for one year in the Division of Biopharmaceutics.Upon leaving the FDA in 1990, she worked for an international pharmaceutical company where she was directly involved in global project management and the business and operations aspects of pharmaceutical development.Subsequently, she joined a mid-size consulting firm in Washington, D.C., where she headed the Pharmaceutical R&D and Regulatory Practice.Dr. Kook provided a broad scope of services to an international clientele encompassing not only a wide range of FDA-regulated products, but also products regulated by the Environmental Protection Agency, and provided technical and strategic support to counsel in product liability litigation.

Karin A. Kook, Ph.D.

Karin A. Kook, Ph.D. - Principal and Managing Director

Karin Kook, Ph.D., Regulatory Consultant
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Karin Kook, Ph.D. backRegulatory Consultant

Dr. Karin Kook's technical expertise is in the clinical and regulatory aspects of product development through her role as founder and president of Salamandra.Salamandra provides a broad range of services to international clientele covering a wide range of both FDA- and EPA-regulated products.Dr. Kook has also headed the Pharmaceutical R&D and Regulated Practice for a Washington-based consulting firm, and previously worked as a medical reviewer in the FDA Center for Drug Evaluation and Research, Division of Neuropharmaceutical Drug Products.

Karin A. Kook, Ph.D.Managing Director