We look forward to Jeanine’s outstanding leadership as we expand the breadth of strategic consulting services we offer our clients.
Madison, VA (PRWEB) June 27, 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). 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
NDAP 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 and investment funds. The highly experienced Principals and Premier Experts of NDA Partners include two former FDA Center Directors and an extensive international team of former pharmaceutical and medical device industry senior executives and regulators. Services include expert consulting, product development planning, regulatory strategy, advisory boards, product assessments and due diligence, litigation and patent support, and associated support projects.