Build a Clinically Credible, Regulatory-Ready Healthcare R&D Centre in India

FDA 21 CFR Part 11 governs electronic records and electronic signatures in regulated environments. For a clinical GCC, this means: audit-trail-enabled systems (tamper-evident, time-stamped logs of all activity), electronic signature framework (unique user IDs, two-factor authentication), system validation (IQ/OQ/PQ lifecycle documentation), access controls with role-based separation, and data integrity controls preventing modification without trace. Our FDA 21 CFR Part 11 Compliance Kit provides pre-built validation protocols, audit trail templates, and signature policy frameworks compatible with Medidata Rave, Veeva Vault, and Oracle Health.

Bengaluru leads for clinical AI, digital health, and MedTech engineering — strongest health tech GCC cluster (UHG, Optum, Medtronic, Abbott). Hyderabad is the stronger choice for drug discovery and computational biology — proximity to the Genome Valley biotech cluster, ICMR institutes, and established pharma company presence (Dr. Reddy’s, Biological E, Aurobindo). For a GCC with both clinical technology and drug discovery scope, a dual-city model (Bengaluru engineering centre + Hyderabad research team) is increasingly common.

CDISC (Clinical Data Interchange Standards Consortium) defines the data standards for clinical trial submissions to FDA and EMA — specifically SDTM (Study Data Tabulation Model) for raw data and ADaM (Analysis Data Model) for statistical analysis datasets. Any GCC performing clinical data management, biostatistics, or regulatory submission work must produce CDISC-compliant datasets. Clinical data managers without CDISC experience cannot produce regulatory-grade submission packages. Sansovi GCC maintains a bench of CDISC-certified CDMs available for 4-week deployment.

DPIIT’s 100% FDI under automatic route for pharmaceuticals, CDSCO Medical Device Rules 2017 streamlined approval pathway, National Medical Devices Policy 2023 cluster development support, Karnataka GCC Policy 2024 for workspace and infrastructure incentives, and the PLI scheme for pharmaceutical manufacturing (for GCCs with manufacturing linkage). The National Digital Health Mission (ABDM) provides data ecosystem access for health digital platforms. We guide healthcare GCCs through all applicable schemes as part of our regulatory setup engagement.