AIP and Data Integrity

  • Overview
  • Why Work With NSF?

Data integrity has become a pressing issue with many regulatory authorities in light of several high-profile instances of data integrity violations. The most egregious data integrity violations may invoke the FDA’s Application Integrity Policy (AIP), which calls the reliability of data in a drug application into question. All pending drug applications would no longer be reviewed by the FDA until the accuracy and reliability of the data can be confirmed.

An independent third party is required in cases of AIP to verify the accuracy and reliability of the data submitted in drug applications against the actual data produced by the firm. NSF Pharma Biotech has served as a third-party data integrity expert to verify the accuracy and reliability of data submitted in NDA and ANDA drug applications to the FDA. We have also led to the development of comprehensive corrective action operating plans (CAOP) to remediate the conditions that led to the data integrity issues and have helped companies implement systems and practices to prevent future occurrences.

For more information about NSF Pharma Biotech regulatory enforcement action support in the U.S., email uspharma@nsf.org or call +1 202.822.1850.

For more information about NSF Pharma Biotech regulatory enforcement action support in Europe, email pharmamail@nsf.org or call +44 1751 432 999.

Why Work With NSF?

Our team includes former U.S. FDA inspectors and experts who have unique expertise in performing third-party data integrity reviews, including reviews as part of the FDA’s Application Integrity Policy.  Our services and skills are known and trusted by both industry and regulators.

See all related news

See all training

Pharma / Biotech Mailing List

Health Sciences Newsletter

View Mailing List Archives

close