Data Integrity Support for Pharma and Biotech

Our team of former regulators and industry experts conducts thorough pharmaceutical data integrity reviews and audits, providing pragmatic recommendations for improvements and remediation.

We help companies lift import bans associated with data integrity observations and assist with data integrity reviews under the FDA’s Application Integrity Policy (AIP) and other international regulatory agency expectations.

Our audits review every aspect of your records and data recording practices, including manufacturing, laboratory systems and electronic storage. We also verify the accuracy and reliability of data submitted in drug and biologic regulatory filings and applications.

We conduct audits of CMOs, CTOs, CROs and other service providers or prospective suppliers.

We offer mock inspections with a data integrity focus. Our staff of former FDA and MHRA regulators prepares your company for the real thing.

We work collaboratively with you to identify system weaknesses and find solutions using a risk assessment approach.

We offer a full range of services from gap assessments to remediation support.

Gap assessments determine the scope of the problem. Our services include:

• Addressing cultural root causes of pharmaceutical data integrity issues
• Applying systemic data integrity remediation, which can be incorporated as part of the overall quality management system
• Providing training and education to all levels of an organization
• Supplying specific computer system expertise for compliance with 21 CFR Part 11 and EU Annex 11 required controls
  

We provide pharmaceutical remediation support for regulatory actions, including:

• EMA/ MHRA critical inspection findings
• EMA/ MHRA statements of non-compliance
• U.S. FDA Form 483s
• U.S. FDA warning letters
• U.S. FDA consent decrees
• U.S. FDA Application Integrity Policy (AIP)
• U.S. FDA import alerts (DWPE)