José Gomes
November 24, 2023

GCP Audits - A new piece in our compliance puzzle

At Owlpharma we are already preparing 2024 maintaining our approach of continuous improvement and development of new capabilities to be ready to meet the expectations of our customers providing high-quality services for the whole Pharma and Health care industries.

2023 was a debut year for Owlpharma’s Audits department but not a quiet one. We have successfully launched our audit reports & planning platform, AuditSearch and we were all around the world (and sometimes remotely) executing audits on behalf of our partners.

We have executed audits across different scopes, including GMP/GDP/ISO 9001:2015 Audits, Pharmacovigilance audits and audits to MA Dossiers. Taking advantage of the combined expertise of our departments and auditors, we were able to also execute cross-functional audits and cover multiple scopes within the same audit process.

Now, as a next step in our journey through the compliance world we have successfully trained our team who developed a robust process for GCP Auditing. We are glad to inform that we are currently able to assist you in the execution of the following types of audits:

  • Investigator Site Audits;
  • Sponsors and IMP Manufacturers’ audits;
  • Critical Document Audits (e.g. Clinical Trial protocol, Case Report Forms, etc.);
  • Audits to Third Parties.

If you need any additional clarification or support, let us know.

We are here to keep your business running.

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