GCC for Pharma & Life Sciences: Own Your Drug Development Operations in India
Pharmacovigilance, clinical data management, regulatory affairs, medical writing, biostatistics. Build India teams that handle your trial data under your governance, not a CRO's. FDA-ready infrastructure from day one.
Ready Infrastructure
Aligned Systems
Pharma Clients
India Offices
What Pharma Teams Build in India
We help pharma and biotech companies build India teams across the drug development lifecycle.
Pharmacovigilance
Adverse event processing, signal detection, periodic safety reports (PSUR/PBRER), and risk management planning. FDA and EMA compliance standards built into every workflow.
Clinical Data Management
Database design, data entry, query management, medical coding (MedDRA, WHO-DD), and database lock activities for clinical trials. Your trial data, your systems, your governance.
Regulatory Affairs
Submission preparation (eCTD), labeling, post-market surveillance documentation, and regulatory intelligence across FDA, EMA, PMDA, and other agencies.
Medical Writing
Clinical study reports, investigator brochures, regulatory submission documents, and scientific publications. Writers with therapeutic area expertise, not generalists.
Biostatistics
Statistical analysis plans, interim analyses, integrated summaries of safety and efficacy, and data visualization for clinical trial programs.
Quality Assurance
GxP compliance, audit support, CAPA management, deviation investigations, and quality systems management for pharmaceutical operations.
Why Pharma Companies Are Moving from CROs to Owned Centers
Contract research organizations served pharma well for decades. But the economics and the risks have changed. Here is what is different now.
Data Ownership
Your clinical trial data, your pharmacovigilance signals, your regulatory submissions. In a CRO model, that data sits in the CRO's systems. In an owned center, it sits in yours. When AI transforms drug safety signal detection (and it already is), the company that owns the data owns the advantage.
Regulatory Audit Control
When the FDA audits your pharmacovigilance operation, they audit YOU. In a CRO model, your audit readiness depends on the CRO's documentation practices. In an owned center, you control the SOPs, the training records, the deviation investigations, and the audit trail.
Institutional Knowledge
A pharmacovigilance team that has worked on your compound for three years knows every adverse event pattern, every coding nuance, every regulatory quirk for your therapeutic area. That knowledge does not transfer when you switch CROs. In an owned center, it compounds.
Cost Structure
CRO markups on Indian pharmacovigilance talent run 50-80% above direct cost. Biostatistics margins are even higher. An owned center eliminates the markup and gives you direct access to India's deep pharma talent pool.
Capacity Control
CRO capacity is shared. When multiple sponsors ramp simultaneously, your timelines slip. An owned center gives you dedicated capacity that scales on your schedule, not the CRO's.
Built for FDA-Regulated Operations
Every pharma GCC we build starts with the regulatory framework required by your program and your auditors.
Why India for Pharma Operations
India has the largest number of FDA-approved manufacturing facilities outside the United States. The country produces over 200,000 pharmacy graduates and 50,000 life sciences PhDs annually. Hyderabad, Pune, and Mumbai are established pharma hubs with deep talent pools in pharmacovigilance, clinical data management, regulatory affairs, and biostatistics. Reliable Group recruits across all six India cities, matching your therapeutic area requirements to the talent markets where that expertise concentrates. The talent exists. The question is whether it works for a CRO or for you.
A US Pharma Services Company Built a 30-Person Pharmacovigilance Team in India
A US-based pharmaceutical services company needed to scale pharmacovigilance and clinical data management capacity to support a growing sponsor base. CRO subcontracting was eating into margins and creating quality inconsistency. They launched an India center under the COPO model with Reliable Group managing infrastructure, compliance setup, and talent acquisition.
Within four months, 30 pharmacovigilance and CDM professionals were onboarded and processing adverse events against FDA and EMA timelines. GxP-aligned SOPs were in place from week one. The India team now handles case processing, MedDRA coding, and signal detection for multiple sponsor programs. Quality metrics match the company's US operations, and the direct cost savings funded expansion into regulatory affairs.
Build Your Pharma India Center
Talk to our team about building FDA-ready India operations for your drug development programs. We will walk through your therapeutic areas, your regulatory requirements, and a realistic timeline.