Quality assurance & compliance
Beyond writing, we ensure that your projects remain audit-ready and fully compliant at all times.
Comprehensive audit and quality assurance
Compliance Audits
GCP, GLP and bioanalytical facility audits
TMF Reviews
Trial Master File and documentation reviews
Vendor Qualification
Vendor and laboratory qualification
Protocol Verification
Verification of protocols, SOPs, CRFs and eCRFs
Source Data Verification
SDV and data integrity checks
CAPA Planning
Process validation and corrective actions
Inspection Readiness
Regulatory inspection readiness support
Training Programs
Tailored training on QA, GCP and compliance
Audit expertise you can rely on
Every audit is conducted by qualified professionals with years of hands-on experience.
System Audits
Facilities, processes and SOPs
Study-Specific Audits
Protocols, investigator sites and data systems
Mock Inspections
Preparing teams for DCGI, USFDA, EMA and other authority visits
Regulatory alignment you can trust
Our services strictly follow international guidelines and standards.
- ICH-GCP, GLP, WHO-GCLP
- 21 CFR Part 11 (Electronic Records & E-signatures)
- CDSCO and International Authority Requirements
- ISO 9001:2015 & ISO 27001:2022 certified operations
Ready to advance your clinical research?
Contact us today for a free consultation and let our experts help you design and implement effective clinical trials that drive your research forward.
+91-9828676917 · Mon–Fri, 9AM–6PM