Your outsourced Regulatory Affairs department — CDSCO, FSSAI & cross-functional compliance, Always...
A dedicated CliniExperts team managing your full regulatory ecosystem — CDSCO, FSSAI, IBSC, RCGM, ICMR, WPC, BIS, BARC and more — on a monthly retainer.
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About our Retainer services
CliniExperts, your trusted partner in navigating the complex regulatory landscape of India. With our Regulatory Retainer Programs, gain the assurance of compliance across CDSCO, FSSAI, and more. As regulations evolve rapidly, let us help you stay ahead, ensuring your products meet all necessary standards without any hassle. Choose us to keep your business compliant and competitive, no matter the changes in the regulatory environment.
For Pharmaceutical, Biologicals, Medtech, Cosmetic and Nutraceutical companies, compliance today extends far beyond a single body — from CDSCO and FSSAI to IBSC, RCGM, ICMR, WPC, BIS, BARC, AYUSH and several other product-specific authorities. Staying compliant demands continuous oversight, not reactive support.
Why This Service Exists
In India, regulatory risk rarely comes from one missed form. It builds from fragmented oversight, delayed responses, missed renewals, overlapping jurisdictions and reactive decision-making.
India’s Regulatory Ecosystem:
CliniExperts Services bouquet
India’s Regulatory Ecosystem Is Not Just CDSCO
India’s regulatory system extends beyond CDSCO, requiring approvals from multiple ministries. CliniExperts offers cross-functional expertise, continuous regulatory tracking, and a single accountable partner for seamless compliance.
Biologics, Biosimilars, Stem Cells & Cell Gene Therapy (CGT) products
For advanced therapies — including biologics, cell and gene therapies, and stem cell products — regulatory coordination involves multiple specialized authorities, each with distinct mandates and review processes. A single product may require clearances and oversight across:
Medical Devices-Electronics, wireless & Radiation emitting devices
For Medical Device manufacturers and importers — particularly those dealing with electronics, wireless-enabled or radiation-emitting products — compliance extends well beyond MDR registration into technical standards, spectrum approvals and equipment certification. A single product may require clearances across:
Pharmaceuticals, Nutraceuticals & Cosmetics
For pharmaceutical, nutraceutical and cosmetic companies — particularly those managing multi-product or multi-category portfolios — compliance frequently spans overlapping frameworks across Drug, Food, Cosmetic, packaging and sector-specific authorities. A single portfolio may require active oversight across:
Who This Is For
Our retainer model helps you move from regulatory firefighting to regulatory control.
Pharma & Biologics Manufacturers
Domestic Drug and biologics companies managing CDSCO/State FDA filings, Schedule M, PvPI obligations, and multi-body approvals (IBSC, RCGM, ICMR) for advanced therapy products.
Medical Device & IVD companies- Importer and Manufacturers
Medical Device & IVD companies Importer and manufacturers navigating MDR 2017, technical dossiers, and cross-functional filings at CDSCO, WPC (ETA),LM, BIS, BARC, CPCB and PCPNDCT
Pharma & Biologics Importers
Foreign manufacturers and Indian importers needing a reliable Authorized Indian Representative (AIR) and end-to-end India compliance across CDSCO.
Nutraceutical, Cosmetic & OTC brands
Brands managing the FSSAI–CDSCO overlap, FoSCoS licensing, health claim filings, compliance, and label compliance across their SKU portfolio.
Our Retainer Tiers
All retainer tiers include regulatory strategy development and regulatory intelligence to identify and prioritise product opportunities within your target therapeutic area or segment. (included in all tiers)
SILVER TIER
Compliance Essentials
Best for companies with a stable product portfolio needing ongoing regulatory intelligence, proactive compliance monitoring, and foundational regulatory strategy advisory.
Real-time circular, gazette & alert notifications from Regulatory bodies such as CDSCO, FSSAI, Legal Metrology, WPC, BIS , CPCB etc- License & registration renewal tracking across all applicable bodies
- Regulatory query handling (up to 5/month/ product)
- Monthly compliance status report with regulatory calendar
- Cross-functional body alert service (WPC, BIS, BARC, IBSC, ICMR circulars)
GOLD TIER
Active compliance management
For companies with ongoing filings, license renewals, and pharmacovigilance obligations. Includes active regulatory strategy, hands-on submission support, and coordination with cross-functional bodies.
Everything in Silver- GAP analysis of the complete dossier.
- Dossier preparation assistance & application filing for all the products
- Schedule M GMP compliance advisory
- PV support — ICSRs & PSURs (PvPI / NCC-PvPI at IPC Ghaziabad)
- Dedicated named RA manager with 24h query SLA
- Quarterly regulatory strategy & review meeting
PLATINUM TIER
Full outsourced RA Department
Platinum Tier offers a fully outsourced regulatory affairs function with deep expertise, dedicated bandwidth, and end-to-end accountability for companies navigating India’s complex multi-authority approval landscape.
- Everything in Gold
- Pre-inspection audit readiness
- ISO 13485 & CE Mark gap assessment
- 4-hour priority query response SLA
- Annual portfolio compliance
- Filing of all applications and query resolution till approval
- Annual filing of Returns
- Compliance and label check for the products.
Important note : Our retainer packages are highly customizable to suit your business needs. We can design a suitable service package tailored for you, readily available at your fingertips.
What You Get in
Every Retainer Program
Regulatory strategy (all tiers) Cross-functional body monitoring Monthly compliance report Dedicated point of contact Regulatory intelligence Annual contract, quarterly reviewReady to make compliance a competitive advantage?
Tell us about your product portfolio and regulatory obligations across all applicable bodies. We will design a retainer that covers your full compliance ecosystem.
Frequently Asked Questions
Does regulatory strategy come at an extra cost, or is it part of the retainer?
Regulatory strategy development is included in all tiers — Silver, Gold, and Platinum. The depth scales with the tier: Silver covers product-level pathway mapping, Gold includes active cross-functional filing coordination, and Platinum provides a comprehensive multi-body strategic roadmap including international frameworks.
We are developing a biosimilar / stem cell therapy. Can you manage IBSC and RCGM filings?
Yes. Our Gold and Platinum retainers include active support for IBSC (Institutional Biosafety Committee) documentation and RCGM (Review Committee on Genetic Manipulation) filings, in addition to CDSCO. Platinum clients also receive GAEC coordination and DBT liaison support for advanced therapy products.
Our medical device has wireless functionality and emits radiation. How do you handle WPC, BIS, and BARC?
Gold retainers include WPC Equipment Type Approval (ETA) filing coordination and BIS compulsory registration support. Platinum retainers add BARC radiation safety clearance support. All tiers receive monitoring alerts from these bodies as part of the cross-functional regulatory intelligence service.
Can CliniExperts act as our Authorized Indian Representative (AIR) under MDR 2017?
Yes. CliniExperts provides AIR services for foreign medical device and IVD manufacturers, fulfilling all obligations under MDR 2017 Rule 8 — including CDSCO submissions, post-market surveillance coordination, and regulatory correspondence on your behalf.
We manufacture both drugs and devices. Can one retainer cover both?
Absolutely. We design integrated retainers for multi-category manufacturers covering obligations under the NDCT Rules 2019 (drugs) and MDR 2017 (devices), along with any applicable cross-functional bodies, under a single account manager and monthly fee.
Is project work (e.g. clinical trials, large dossiers) included?
No — project work is scoped and billed separately. Retainer clients receive priority scheduling and preferential rates on all project engagements. Your retainer manager ensures seamless handoff.
How quickly can we get started?
After a proposal is accepted, onboarding takes 5–7 working days. This includes introduction to your RA manager, a regulatory audit of your existing portfolio across all applicable bodies, and delivery of a 90-day priority action plan.