MADISON, VIRGINIA (June 25, 2013) – Carl Peck, MD, Chairman of NDA Partners LLC (NDAP), announced today that Jeanine Kuczik has been appointed a Partner in the firm. Ms. Kuczik is a regulatory expert with extensive experience working with Biopharma companies to manage their preclinical, CMC, and clinical programs, develop regulatory strategies, prepare regulatory submissions, and interact on their behalf with the US Food and Drug Administration (FDA). According to Dr. Peck, “Jeanine is a fantastic resource for our clients and has played a key role in the growth of our consulting practice. We look forward to Jeanine’s outstanding leadership as we expand the breadth of strategic consulting services we offer our clients and provide more comprehensive solutions for the medical products industry.”
In her role at NDA Partners, Ms. Kuczik develops regulatory strategies and provides oversight of FDA submissions including Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs) [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm]. She routinely provides project management for regulatory projects, interfaces with the FDA, assists clients in the preparation of briefing packages for FDA meetings, arranges and provides oversight of electronic submissions, and serves as a virtual regulatory affairs department for early-stage companies. Recent projects have included products in therapeutic areas such as neurology, pain, psychiatry, urology, and cardiovascular drugs. Prior to her consulting career, Ms. Kuczik held roles of increasing responsibility at Glaxo Inc, including Assistant Director of Regulatory Affairs for the company’s anti-infective, neurology, and dermatology drug products. She holds a BS in Pharmacy from the University of Connecticut.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include two former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of approximately 40 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
Earle Martin, General Manager