Sometimes the FDA will find serious problems in the manufacturing or quality of products. Unsafe handling of products or contamination may force the FDA to seek a consent decree in order to have a company cease and desist production or sale of a product until it complies with all federal laws that are set forth for the safe production of pharmaceutical products and devices.

Application Integrity Policy (AIP) focuses on the integrity of data and information in applications submitted for FDA review and approval. The AIP describes the Agency’s approach regarding the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability.

Pharmaceutical Services Corporation can lead or aid your company in conforming to the items indicated in the consent decree. Rigorous methods, extensive manpower and expertise may be required for such activities. We understand the requirements of the FDA and the implications of the decree, and so we are able to provide the appropriate specialist for your company’s needs.