Data Integrity Support for Pharma and Biotech

We offer training, risk evaluations, audits and collaborative systems assessments to assist with your ongoing data integrity needs. Our experts also provide guidance for addressing regulatory findings and implementing data integrity governance systems.

Data Integrity Audits

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.

Third-Party Data Integrity Audits

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

Mock Inspections

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

Data Integrity Risk Assessment (DIRA)

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

Data Integrity Remediation Response

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

Gap Assessments

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 organisation
Supplying specific computer system expertise for compliance with 21 CFR Part 11 and EU Annex 11 required controls

Remediation Support

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)

Resources

How the QA and QP Talent Market Is Changing in Pharma: Insights from Compliance Unlocked Podcast
Podcast
Recruiting and retaining experienced quality and regulatory professionals has become significantly more complex for pharmaceutical and biotech companies.
The Foundations of Pharmaceutical Compliance for Beginners
Article
Whether you’re stepping into the pharmaceutical industry for the first time or pivoting into a compliance or quality assurance role after years of experience, mastering the fundamentals of quality and regulatory compliance is vital to your success—and to the success of your organization.
What’s Really at Stake When Trade Policy Shifts? For Life Sciences Companies, Everything
Brochure
With the right strategies in place and the right partners, life sciences businesses can mitigate tariff impacts, protect their innovation pipelines, and emerge more resilient in the face of global trade uncertainties.