GxP Audits & Compliance Assurance for Pharma, Biotech and Medical Devices

Owlpharma provides comprehensive auditing services designed to help pharmaceutical, biotechnology, medical device, and healthcare organizations ensure compliance, mitigate risks, and maintain the highest quality standards throughout their operations. Our experienced auditors bring extensive expertise in international regulatory requirements and audit reference standards, delivering independent and value-driven assessments.

Our portfolio includes:

• Pharmacovigilance Audits: Internal audits and audits of outsourced service providers and contractors.

• GMDP, GACP & Medical Device Audits: Supplier, distributor, wholesaler, manufacturer, and Contract Manufacturing Organization (CMO) audits, as well as internal quality system assessments.

• GCP Audits: Investigator site audits, sponsor audits, IMP manufacturer audits, and critical clinical documentation reviews, including protocols and CRFs.