Compliance & SOP
Compliance without compromise.
Every Proclin workflow is validated against 21 CFR Part 11, GDPR, ICH-GCP and international confidentiality laws — across our India and Europe operations.
Regulatory Frameworks
Built to withstand scrutiny
21 CFR Part 11
United States — FDA: Validated electronic records and signatures with tamper-evident audit trails, unique credentials and time-stamped e-signatures.
GDPR
European Union: Lawful basis for processing, data minimization, subject rights and robust technical and organizational safeguards.
ICH-GCP
International: Good Clinical Practice adherence across every trial — protecting participant rights, safety and data credibility.
DCGI / CDSCO
India: Full compliance with New Drugs and Clinical Trials Rules, 2019, and end-to-end DCGI submissions.
Confidentiality Laws
Global: Adherence to international confidentiality and data-protection laws for cross-border programs.
Standard Operating Procedures
Proclin SOPs: Comprehensive internal SOPs governing change control, monitoring, data management and quality assurance.
Standard Operating Procedures
Documented. Validated. Auditable.
Our SOPs form the operating backbone of every program — traceable from specification to test, and continuously reviewed against evolving global guidance.