Our Services
PV Audits QA & Inspection
Complete range of PV audits undertaken, such as Affiliate Country Office, System Audit, Vendor Audit, Co Marketing Partner Audit, with recommended CAPAs & Audit Certificate in any geography.
Development of QA system for PV activities, such Master Quality Plan, Risk based Internal Audit Strategy
Facilitate MAH for Inspection Readiness & assistance in preparing MAH's responses to Inspection findings
Quality Management System
Technology based Management of Audits, Inspection & CAPAs
GXP Auditing Services
- Investigator Site GCP audits
- GCP System audits (Sponsor and CRO)
- CRO audits (due diligence audits)
- Vendor Qualification Audits
- Phase 1 audits
- Investigational Product Supply and Management audits
- IT system Qualification audits
- Archival site audits
- Drug Destruction Unit audits
- Data Management Audits
- For cause Investigator Site audits
- GCLP Audit
- GLP Audits
- GMP Audits
- Remote Audits
Corporate Training
Developing training matrix, plans & training material
Conducting 'Boot Camp' and training stake holders in a MAH set up
Customized training on Good Pv Practices, Safety Regulation Updates, etc
Providing customized training material & Corporate Training