Complying with the ever changing requirements of state and federal pedigree regulations can be a daunting task. Porzio expertly assists pharmaceutical and medical device manufacturers and wholesale distributors in meeting their existing pedigree obligations, while continuously monitoring state and federal pedigree requirements to ensure that clients stay ahead of the curve.
We counsel clients on the individual nuances of varying state pedigree laws and offer guidance on how best to adapt existing internal distribution procedures to implement effective processes that comply with the most recent requirements. As distribution methods become more complex, we work with clients to assess potential pedigree implications of different models. Our goal is to keep your product moving while keeping you in compliance.
Unique to Porzio is our wholly-owned subsidiary, Porzio Life Sciences, which offers a Porzio Compliance Module that provides "at-a-glance" information, obtained through exhaustive review of the voluminous statutes, regulations and agency rules on federal and state pedigree requirements.
Our Pedigree Requirements Module offers updates on both enacted and pending pedigree requirements in the PDMA, all 50 states and the District of Columbia.