Investigator Sites: Our experienced auditors conduct routine, directed, and for-cause audits of investigator sites including Phase 1 and Biovailability and Bioequivalence Centres to assess compliance to protocol and applicable regulatory standards including ethical practices and patient safety criteria.

Trial Master File: Review essential documents per GCP requirement that collectively demonstrate compliance with GCP and applicable regulatory standards.

Pharmacovigilance: Our experience auditors perform a systemic and independent examination of PV activities performed by different stakeholders which include Sponsors, Business Partners (BP) / Distributors, Vendors (Market Research, Non-interventional study, Patient Support Programmes, Specialty Pharmacies etc).

Data Management: Assess clarity, consistency and quality of trial data. Ensure robust processes has been implemented to collect and analyse the information. Generate credible reports that can withstand regulatory scrutiny.

Computer System Validation: Our experienced auditors review validation documentation and verify processes to ensure clients can demonstrate compliance with applicable regulatory requirements.

Vendor Qualification: The primary objective of these audit is to assess the facilities, systems and procedures followed by the vendors / CROs to be able to meet Sponsor’s expectation and industry standards. This is also followed by periodic formal reviews to assess any potential risk and / or non-compliance and ensure vendor continue to meet sponsors KPIs and SLAs

Systems / Process: The objective of these audits are to determine robustness of existing quality systems and consistency of organizational processes, across studies, project teams, locations etc.

GMP Audits: We perform comprehensive audits to assess data integrity practices, quality control activities assessment and Quality Management Systems including qualification of Contract Manufacturing Organizations.

Need Help?
Scroll to Top

Let's discuss your project