Strategic Regulatory Outsourcing for Life Sciences
Scalable, Compliant, and Proven
With 15+ years of experience in India’s evolving regulatory landscape, we support pharma, medtech, and nutraceutical companies across every phase of the product lifecycle4through precision-driven, scalable outsourcing models.
To know more about the rules,
Please Fill the Form
To learn more, connect with us
Regulatory Outsourcing - A Strategic Imperative
In an industry where compliance directly impacts time-to-market, outsourcing is no longer a cost-cutting exercise- it’s a risk-mitigation and scalability strategy.
Maintain submission timelines across multiple jurisdictions
Manage region-specific formats like eCTD, XEVMPD, or India’s SUGAM Portal
Respond rapidly to agency queries and variations
Scale their regulatory capacity without bloating internal teams
We offer a modular regulatory outsourcing approach4enabling organizations to flex between specialized task support and full RA department outsourcing, depending on their internal maturity, project complexity, and market priorities.
Our Regulatory Outsourcing Models
We structure our engagement to match your operational architecture. Whether you need support for India-specific filings, global product launches, or ongoing compliance, our models ensure seamless integration with your internal teams and processes.
Function-Specific Outsourcing (FSP Model)
Focused support for critical regulatory functions
This model supports companies with in-house regulatory teams that need to offload repeatable, high-effort tasks- without losing ownership of regulatory strategy.
Use Cases
- Lifecycle document updates (e.g., labeling, SmPC, patient leaflets)
- Compilation and publishing in eCTD, NeeS, or country-specific formats
- Regulatory intelligence and health authority surveillance
- Clinical trial document handling and archiving (TMF compliance)
Expert Perspective
Many of our clients use this model to bridge operational gaps during pipeline expansion, product acquisition, or restructuring. Our teams function as an extension of your regulatory operations group, following your SOPs and quality systems.
On-Demand Regulatory Support (RAaaS)
Pay-as-you-go access to regulatory experts and infrastructure
This flexible model is ideal for dynamic regulatory environments, where unplanned variations, agency queries, or submissions arise at short notice.
Emergency Regulatory Response
Post-inspection commitments
Labeling Updates
Re-registrations in India
Gap Analysis
For regulatory submissions
Short-term Coverage
For staffing transitions or surges
Expert Perspective: Clients particularly value this model for its scalability and speed4we can deploy a regulatory publishing team within 24348 hours. Ideal for startups and SMEs who can’t afford full-time RA headcount but still need experienced resources on demand.
Hybrid Outsourcing Models
Customized or Shared Responsibility Models
In this collaborative model, clients retain high-level regulatory planning and decision-making, while outsourcing regional execution, operational activities, or specialized compliance tasks to us. A hybrid model combines elements of both in-house and outsourced regulatory functions. Instead of an “all or nothing” approach, companies retain certain regulatory responsibilities internally while outsourcing others.
Use Cases
- Internal strategy team manages global plan; we execute India filings
- Client manages pre-submission activities; we handle post-approval variations
- Shared responsibility for multi-region portfolio with centralized reporting
Expert Perspective
This model is often adopted during transitional phases 4such as mergers, rapid portfolio expansion, or geographic diversification. Our regulatory professionals integrate into your workflows, ensuring real-time communication and synchronized output.
Expertise Across Product Categories
Our deep regulatory knowledge spans across product types regulated under Indian and global frameworks:
Pharmaceuticals
APIs, generic drugs, NDAs, OTC formulations
Biologics
Biosimilars, cell and gene therapies, vaccines
Combination Products
Drug-device, biologic-device hybrids
In-Vitro Diagnostics
High-risk assays, companion diagnostics
Medical Devices
Class A to D, including software as a medical device (SaMD)
Cosmetics
Skin care, oral care, imported and domestic products
Nutraceuticals
Foods for special medical purposes, dietary supplements
Expert Perspective: We understand the nuances of CDSCO’s requirements and the practical application of Schedule M, Schedule Y, and the MDR/IVDR frameworks. Our consultants help you avoid regulatory pitfalls, reduce agency pushback, and maintain approval timelines.
Why Leading Companies Trust Us
With 15+ years of delivering regulatory solutions across 30+ countries, we’ve become the trusted outsourcing partner for startups, global pharma, and everything in between.
100+
Regulatory Experts
Across functional areas
30+
Countries Served
Global regulatory expertise
15+
Years Experience
Proven track record
Regulatory experts across functional areas
Dedicated Regulatory Intelligence Unit to track changing compliance requirements
Proven success with agencies like CDSCO, DCGI, FSSAI, EMA, US FDA, and WHO
India Authorized Agent Support with in-house license-holding capabilities
Expert Perspective: Our mission isn’t just to “get it done”4it’s to get it done right, on time, and in alignment with both local regulations and your global development plan.
