Madison, VA (PRWEB) June 27, 2013
Carl Peck, MD, Chairman of NDA Partners LLC (NDAP), announced these days that Jeanine Kuczik has been appointed a Partner in the firm. Ms Kuczik is a regulatory specialist with extensive encounter functioning 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 great resource for our clientele and has played a crucial part in the growth of our consulting practice. We look forward to Jeanines outstanding leadership as we expand the breadth of strategic consulting services we provide our consumers and provide much more complete solutions for the healthcare items sector.

In her part at NDA Partners, Ms Kuczik develops regulatory strategies and provides oversight of FDA submissions which includes Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs). She routinely offers project management for regulatory projects, interfaces with the FDA, assists clientele in the preparation of briefing packages for FDA meetings, arranges and gives oversight of electronic submissions, and serves as a virtual regulatory affairs division for early-stage companies. Recent projects have integrated goods in therapeutic areas such as neurology, discomfort, psychiatry, urology, and cardiovascular drugs. Prior to her consulting career, Ms Kuczik held roles of growing responsibility at Glaxo Inc, including Assistant Director of Regulatory Affairs for the companys anti-infective, neurology, and dermatology drug products. She holds a BS in Pharmacy from the University of Connecticut.

About NDA Partners
NDAP is a method consulting firm specializing in specialist solution development and regulatory suggestions to the health-related merchandise sector and associated service industries such as law firms and investment funds. The highly skilled Principals and Premier Specialists of NDA Partners include two former FDA Center Directors and an substantial international group of former pharmaceutical and medical device industry senior executives and regulators. Services incorporate expert consulting, solution development planning, regulatory strategy, advisory boards, solution assessments and due diligence, litigation and patent help, and linked help projects.





Far more Administrator Press Releases