GAP will pledge sponsor to update with the rapidly advancing administrative and regulatory necessities. Audit readiness and inspection services provide a complete understanding of the regulatory updates from FDA and other regulatory agencies for the prospective customers. It provides a concise and prioritized list of actions, which will update your clinical procedures. The main area where our team is focused is:
Audits of CROs, Hosting Facilities, clinical and analytical laboratories, investigator site, Ethics Committee/ Institutional Review Boards
Drug packaging, distribution or dispensing
Vendor or supplier Audits
Validation of database, Analytical instruments and computer system
Documents and deliverables Audit: TMF preparation and updation, protocol, ICD, CRFs, chromatograms, tables, listing, Study update report, CSR etc.
Training: investigator site for regulatory inspection
MOCK drills for regulatory inspection
Inspection finding: assist and support in preparation of response for findings
Developing an effective Internal Audit Program integrated with your Quality Regulatory Inspections Awareness Training
- Contact us for more information.