Introduction
Healthcare and life sciences organisations generate and manage large volumes of complex information. Clinical research, medical data, drug development, patient support, regulatory documentation, health technology and commercial operations all require specialised knowledge and reliable processes.
For global companies, a Global Capability Centre in India can provide a base for selected activities across these functions. Depending on its mandate, the centre may support clinical operations, pharmacovigilance, medical writing, data analytics, regulatory affairs, software development or enterprise services.
However, healthcare and life sciences operations come with requirements that are not always present in a conventional corporate support centre. The work may involve sensitive health information, clinical documentation, regulated processes, proprietary research and systems where errors can have serious consequences.
Planning a successful GCC therefore requires a clear understanding of the activities it will perform, the applicable rules, the expertise it needs and the controls required to protect information and maintain quality.
This guide explores the key considerations for establishing a healthcare or life sciences GCC in India.
What Is a Healthcare or Life Sciences GCC?
A healthcare or life sciences GCC is an India-based centre that supports a global organisation’s healthcare, pharmaceutical, biotechnology, medical device, clinical research or related operations.
Its responsibilities may include:
- Clinical trial operations support
- Clinical data management and analytics
- Pharmacovigilance and drug safety support
- Medical writing and scientific documentation
- Regulatory affairs support
- Biostatistics and statistical programming
- Healthcare data analytics
- Medical coding and revenue cycle support
- Drug discovery and research support
- Medical device software development
- Quality assurance and process improvement
- Enterprise technology and cybersecurity
- Finance, procurement and other corporate services
Not every centre will perform all these activities. A pharmaceutical company may focus on regulatory documentation and drug safety, while a healthcare technology business may prioritise data platforms, product engineering and analytics.
The operating model must reflect the organisation’s role in the healthcare value chain and the responsibilities it intends to assign to the Indian centre.
Why India Is Relevant for Healthcare and Life Sciences GCCs
Healthcare and life sciences work often combines domain expertise with technology, data analysis and complex documentation. India’s professional talent pool includes people with backgrounds in pharmacy, medicine, biotechnology, statistics, clinical research, computer science and healthcare operations.
The country also has an established technology services ecosystem that can support digital health platforms, research data systems, analytics and enterprise applications.
The opportunity is not limited to routine support. Depending on its capabilities and governance, a GCC may contribute to scientific analysis, clinical operations, data quality, product development and process improvement.
However, healthcare expertise alone does not guarantee that a centre is ready to perform regulated work. The company must establish appropriate training, documented procedures, review mechanisms and quality controls before assigning responsibilities.
Step 1: Define the GCC’s Healthcare or Life Sciences Focus
The first step is to identify the activities the centre will perform and the level of responsibility it will hold.
Clinical operations
A centre may support clinical trial planning, study documentation, site coordination, data review, reporting or trial management activities. The exact responsibilities depend on the company’s operating model and applicable requirements.
Pharmacovigilance and drug safety
Drug safety teams may support the collection, processing, assessment and reporting of adverse event information. These workflows require clear procedures, accurate documentation, appropriate escalation and adherence to relevant reporting timelines.
Regulatory affairs
Regulatory teams may prepare, review or coordinate documentation required for product approvals, submissions, variations and ongoing compliance activities. The work often requires familiarity with different regulatory markets and disciplined document control.
Healthcare analytics
Analytics teams may work with operational data, claims, clinical information, medical records or other datasets, subject to the relevant permissions and controls. Possible activities include reporting, forecasting, quality analysis and decision support.
Research and development
Research support may include data analysis, statistical programming, scientific literature review, laboratory coordination or other activities linked to product development.
Before selecting an office, document the functions, data types, systems, skill requirements and decision rights associated with each activity.
Step 2: Build a Talent Plan Around the Required Expertise
Healthcare and life sciences GCCs often require a combination of scientific, clinical, regulatory and technology skills.
| Capability | Potential roles |
| Clinical operations | Clinical operations specialists, study coordinators, clinical project managers |
| Drug safety | Pharmacovigilance specialists, safety scientists, case processing professionals |
| Regulatory affairs | Regulatory affairs specialists, submission coordinators, regulatory writers |
| Medical writing | Medical writers, scientific editors, documentation specialists |
| Clinical data | Clinical data managers, data quality specialists, database professionals |
| Statistics | Biostatisticians, statistical programmers, quantitative analysts |
| Healthcare analytics | Data analysts, data engineers, healthcare informatics specialists |
| Research | Research associates, scientific analysts, domain specialists |
| Technology | Software engineers, cybersecurity professionals, platform specialists |
| Quality and governance | Quality assurance specialists, audit support professionals, process owners |
The final hiring mix should follow the work rather than a standard staffing template.
Prioritise domain knowledge
A data analyst working with ordinary commercial information may need a different background from one handling clinical trial datasets. Similarly, a regulatory documentation team needs an understanding of submission processes and the standards relevant to its work.
Define the minimum qualifications, experience and training requirements for each role. Avoid assuming that general administrative or technical experience automatically qualifies someone to perform specialised healthcare tasks.
Establish a structured training programme
Training should cover the organisation’s procedures, data handling expectations, documentation standards, quality systems and role-specific requirements.
Where relevant, employees may need training on good clinical practice, pharmacovigilance procedures, clinical data management or other applicable standards. The company should determine the exact training required for each activity rather than applying a generic programme to every employee.
Training records, assessments and refresher requirements should be documented and monitored.
Step 3: Choose a Location Based on the Talent Ecosystem
Location selection should consider the availability of specialised professionals, recruitment competition, office infrastructure, transport, technology providers and proximity to relevant research or healthcare ecosystems.
Bengaluru
Bengaluru may suit healthcare technology, digital health, data analytics, software engineering and technology-led research operations. Companies should evaluate the availability of professionals with the specific clinical or scientific expertise their functions require, rather than relying solely on the city’s broader technology reputation.
Hyderabad
Hyderabad is worth evaluating for pharmaceutical, biotechnology, clinical research, healthcare technology and related operations. Companies should assess the relevant talent pool, research ecosystem, office options and operational needs for the proposed centre.
Pune
Pune may be relevant for technology-led healthcare operations, analytics and selected research support functions. Its suitability depends on the availability of the required expertise and the company’s recruitment strategy.
Chennai
Chennai may be considered for healthcare technology, medical and scientific support functions, depending on the talent requirements and business model. Companies should evaluate the relevant professional ecosystem and the location’s suitability for the planned activities.
Mumbai and Delhi NCR
Mumbai and Delhi NCR may be relevant for certain healthcare, pharmaceutical, corporate and technology functions. The final decision should depend on the exact skills required, the company’s existing presence, relevant stakeholders and office requirements.
No city should be treated as universally best for every healthcare or life sciences GCC. A regulatory affairs team, a clinical data operation and a medical technology development group may have different location priorities.
Step 4: Understand the Regulatory Environment
Regulatory planning should begin before the centre takes on work, not after the office has opened.
In India, the Central Drugs Standard Control Organization (CDSCO) has responsibilities that include specified drug approvals, clinical trial approvals and related regulatory functions under the applicable framework. Its remit is described on the official CDSCO website.
However, the presence of a healthcare or life sciences GCC does not automatically mean that every activity it performs requires the same approval. Requirements depend on the activity, product, legal entity, data involved and the jurisdictions concerned.
Map the relevant obligations
The parent organisation should work with legal, regulatory, quality and compliance teams to identify the rules and standards relevant to each function.
The assessment may cover:
- Clinical trial responsibilities
- Drug safety and adverse event reporting
- Regulatory submissions
- Quality management systems
- Record retention and audit trails
- Data protection and confidentiality
- Vendor and service-provider oversight
- Cross-border data transfers
- Contractual obligations and access permissions
This list is a planning aid, not a complete statement of legal requirements. The organisation should obtain advice for its particular business and operating model.
Document accountability
For each process, define who performs the work, who reviews it, who approves decisions and who is responsible for escalation.
The GCC may prepare documentation or conduct analysis without being the entity that makes the final regulated decision. Those distinctions should be explicit in procedures, contracts and governance arrangements.
Step 5: Protect Health Information and Research Data
Healthcare and life sciences work can involve personal information, patient records, clinical trial data, research datasets and commercially sensitive scientific information.
The organisation should classify its data and determine the controls required for each category.
Use role-based access
Employees should access only the information required for their responsibilities. Access should be approved, reviewed regularly and withdrawn when no longer needed.
For sensitive datasets, additional restrictions may be appropriate, such as segregated environments, controlled exports, enhanced monitoring or approval requirements for particular activities.
Apply data minimisation
Where the task can be completed using de-identified, pseudonymised or aggregated information, assess whether access to directly identifying information is necessary.
The appropriate approach depends on the purpose, dataset, applicable law and research requirements. De-identification should not be treated as a substitute for a full privacy assessment.
Establish secure handling procedures
Procedures should cover data transfers, downloads, printing, storage, sharing, retention and deletion. The organisation should also assess the use of external tools, including AI systems, before allowing employees to process sensitive health or research information through them.
Review cross-border data flows
A global organisation may transfer data between the GCC and other entities. Before doing so, identify the data involved, the purpose of the transfer, the recipient, the applicable restrictions and the safeguards required.
Legal and privacy specialists should confirm the requirements for the specific jurisdictions and data categories involved.
Step 6: Build Quality Into Everyday Work
Quality is central to healthcare and life sciences operations. Inaccurate data, incomplete documentation or missed procedural steps can affect downstream decisions and create compliance risks.
A quality framework should be proportionate to the work performed.
Standardise workflows
Document the key steps for each process, including inputs, checks, approvals, exceptions and records to be retained. Employees should know which procedures apply and where to find the current approved version.
Maintain traceability
The organisation should be able to determine who performed an activity, what information was used, what changes were made and who approved the result, where those records are required.
Audit trails, version control and review records can help support accountability.
Establish escalation procedures
Employees need a clear route for raising errors, data discrepancies, missed deadlines, suspected security incidents and quality concerns.
Escalation procedures should define ownership, response expectations and the process for documenting corrective and preventive actions where appropriate.
Prepare for audits and inspections
The centre should maintain organised records and clear ownership of relevant evidence. If the GCC supports a regulated process, its procedures should align with the parent organisation’s quality system and the requirements applicable to the work.
Step 7: Select an Appropriate Office and Infrastructure Model
The office should support confidentiality, reliable technology, focused work and collaboration.
A conventional office may be suitable for a large centre with specific fit-out requirements. A fitted or managed office may work for selected functions if it meets the organisation’s security, privacy and operational standards.
The decision should consider:
- Controlled access to the premises
- Private areas for confidential discussions
- Secure network connectivity
- Approved equipment and software
- Meeting rooms suitable for sensitive work
- Visitor registration and access procedures
- Reliable power and connectivity
- Business continuity arrangements
- Space for training and quality reviews
- Expansion capacity
For a centre that conducts physical research, testing or laboratory work, additional technical and safety assessments may be necessary. A conventional office should not be assumed to be suitable for laboratory activities without appropriate review.
Step 8: Decide Whether Specialist Facilities Are Necessary
Some healthcare and life sciences GCCs can operate primarily from office premises. Others may require laboratory access, specialist equipment, controlled environments or relationships with external research providers.
The company should distinguish between work that requires physical facilities and work that can be completed using digital systems, research data or external services.
Where specialist facilities are needed, assess equipment requirements, safety procedures, access controls, environmental conditions, maintenance, calibration and the handling of materials.
A partnership with an external laboratory may reduce upfront investment, but it creates dependencies that need to be managed through clear service agreements, confidentiality provisions, quality expectations and oversight.
Step 9: Build a Realistic Budget
The cost model should reflect the centre’s functions, talent mix, security needs and facilities.
Potential cost categories include:
- Recruitment and specialist training
- Salaries and benefits
- Office rent and facilities management
- Technology platforms and software licences
- Secure infrastructure and access controls
- Quality systems and documentation tools
- Regulatory and professional support
- Data management and cybersecurity
- Laboratory equipment or external testing services
- Business continuity and contingency provisions
A centre focused on medical writing and analytics will have a different cost profile from one that requires laboratory equipment or specialised research infrastructure.
Build a phased budget that distinguishes essential launch costs from investments that can be added as the centre expands. This helps prevent the organisation from committing to facilities or technology before the corresponding business need is established.
Measuring the Performance of a Healthcare or Life Sciences GCC
Performance measures should reflect the work performed and the quality expectations associated with it.
Potential indicators include:
- Recruitment and retention of specialist talent
- Training completion and competency assessments
- Accuracy and completeness of documentation
- Process cycle time
- Quality review findings
- Timeliness of assigned deliverables
- Data quality and reconciliation results
- Audit findings and corrective action closure
- Service reliability
- Contribution to research or product milestones
- Compliance with internal procedures
Speed should never be the only measure of success. Faster processing is not a meaningful improvement if it creates errors, weakens documentation or increases risk.
Healthcare and Life Sciences GCC Setup Checklist
Before launch, confirm that the organisation has:
- Defined the centre’s scope and responsibilities
- Identified the applicable regulatory and quality requirements
- Mapped sensitive data and cross-border data flows
- Created a specialist hiring plan
- Established role-specific training requirements
- Documented process ownership and approval rights
- Implemented appropriate data access controls
- Defined quality review and escalation procedures
- Selected a suitable office and technology environment
- Assessed any laboratory or specialist facility requirements
- Built a phased budget and operational plan
- Established performance measures for quality and delivery
Conclusion
A healthcare or life sciences GCC can support global operations across clinical research, regulatory affairs, analytics, technology and other specialised functions. Its effectiveness depends on matching the centre’s responsibilities with the right talent, systems and governance.
Businesses should start by defining the work the GCC will perform and identifying the rules, quality standards and data controls that apply. Those requirements should guide hiring, office selection, infrastructure design and the choice of external partners.
A clear operating model helps the centre contribute to global business goals while maintaining the quality, security and accountability expected in healthcare and life sciences.
