Nutraceuticals
Can I sell this as a supplement, and what am I allowed to say about it?
FSSAI category and claims work for supplements, functional foods and foods for special dietary use.
Nutraceuticals · Medical Devices · Cosmetics · Pharmaceuticals
A Market Accelerator for regulated products
We help innovators move from R&D to market through coordinated scientific, regulatory, clinical, quality, manufacturing and commercialisation support — so the route is settled before the evidence is commissioned.
- ICH-GCP aligned
- CDSCO & DCGI pathways
- Audit-ready TMF
- Pan-India Coverage across major trial sites
- Since 2010 Operating
- ICH-GCP aligned E6(R3)
- FSP & vendor model Under your SOPs and oversight
What we do
Four sectors, different regulatory frameworks
Prequel is a Market Accelerator for nutraceuticals, medical devices, cosmetics and pharmaceuticals — helping innovators move from R&D to market through coordinated scientific, regulatory, clinical, quality, manufacturing and commercialisation support.
Medical Devices
What class is my device, and what evidence does that route require?
Classification, risk management, technical documentation and quality systems for CDSCO and EU routes.
Cosmetics
What does it take to put this cosmetic on the Indian market?
COS-1 and COS-2 import registration, State licensing, labelling and claim control for the Indian market.
Pharmaceuticals
How do I get this study approved and run in India?
Clinical trial approval, study execution and the full functional stack — our longest-running capability.
A supplement, a face cream, a tablet and a catheter answer to different authorities under different legislation. The boundary between them — where a claim moves a product from one category into another — is where most avoidable cost sits. How we work across the four.
Regulatory routes
The pathway decides everything downstream
Classification determines what testing and what evidence your product needs. Settle it first and the rest is planning; settle it late and it is rework.
Market-access routes
FSSAI — NutraceuticalsAYUSH — ASU productsCDSCO — India510(k) — US FDADe Novo — US FDAPMA — US FDAEU MDR 2017/745Cosmetics — IndiaNDCT 2019 — clinical trials
Supporting standards — not approval routes on their own
Delivery
The teams that do the work
A regulatory route sets what has to be produced. These are the functions that produce it — the same capability we have run as an FSP for CROs, SMOs and sponsors, now working across all four categories.
Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
Pharmacovigilance Support
ICSR intake/processing, E2B checks, QC & medical review support per client safety SOPs.
Clinical Data Management Support
EDC/eCRF build & validation, DMP/edit checks, coding, queries, freeze/lock support.
Biostatistics & Statistical Programming
SAP, SDTM/ADaM mapping, TLF programming & QC; submission-ready outputs.
Medical Writing
Protocol/IB, CSR, narratives and statistical sections aligned to TA context.
Quality • Compliance • Reliability
Trusted clinical research support partner in India (FSP/Vendor Model)
We support CROs, SMOs and sponsors with SOP-driven processes aligned to ICH-GCP and India’s regulatory pathway expectations. Our teams work under client oversight to keep documentation complete and TMF inspection-ready. We provide EC/DCGI coordination support and dossier preparation as requested; submissions are executed by the sponsor/CRO or by us only when formally authorized.
Our Assurance Pillars
GCP
ICH-GCP Alignment
Study conduct, documentation, and oversight mapped to global good-clinical-practice expectations.
EC
EC / DCGI Familiarity
Predictable submissions and responses across CDSCO / DCGI pathways and Ethics Committees.
QMS
SOP-Driven Quality
Role-based SOPs, training records, and CAPA discipline to maintain inspection readiness.
TMF
Audit-Ready TMF
Health checks, version control, and document governance for clean TMF at closeout.
Standards & Regulatory Frameworks We Operate Within
ICH-GCPGVPCDSCO / DCGIEC / IEC21 CFR Part 11 (aware)ICMRSchedule YSOP-Driven QualityAudit-Ready TMF
*Statements describe internal SOP alignment and operating practices; certificates and vendor tools are disclosed under NDA when applicable.
How we work
How We Work with CROs & SMOs (FSP/Vendor Model)
A standardized, SOP-driven process that keeps governance clear, timelines realistic, and your TMF inspection-ready. We align with ICH-GCP and India’s CDSCO/DCGI pathways while maintaining transparent communication throughout the study.
- 01
Discovery & Feasibility
- Protocol synopsis review & risk assessment
- Country/site fit, investigator interest checks
- Feasibility report with timelines & budget bands
- 02
Start-Up & EC/DCGI Submissions
- EC/IEC dossier prep & response coordination (approvals managed by sponsor/CRO)
- Contracts, budgets, and site activation readiness
- Study initiation visits & training records
- 03
Execution & Oversight
- Monitoring plan (RBM), SDV/SDR, follow-ups
- Data review, query management, safety case flow
- Issue/CAPA governance with KPI dashboards
- 04
Closeout & Submission
- Freeze & on-time Database Lock
- CSR & narratives support; TMF health checks (submission executed by client or by us when authorized)
- Archival & inspection readiness support
Governance & Communication
- Dedicated PM, RACI matrix, and RAID log
- Weekly touchpoints and monthly governance reviews
- Risk-based quality oversight and TMF status reporting
Engagement
Engagement Models & Onboarding (FSP/Vendor)
We provide functional service provider (FSP) support to CROs, SMOs and sponsors—working inside your validated environments and under your SOPs & oversight. Choose a model below or mix-and-match for scale.
Model 01
Dedicated FTEs (Onsite / Remote)
Best for throughput & continuity
- Role-based allocation (CRA/CRC, CDM, PV, Biostats/SAS, MW)
- Time & materials with agreed SLAs
- Back-up coverage and holiday planning
Model 02
Project SOW / Work Order
Best for fixed scope & milestones
- Defined deliverables and acceptance criteria
- Milestone billing linked to outputs
- Ideal for start-up packets, UATs, TLF batches, CSRs
Model 03
Hybrid Augmentation
Best for surge & specialized tasks
- Blend dedicated FTEs with task-based tickets
- Rapid scale-up/down with monthly governance
- Useful for coding backlogs, narrative bursts, SDV/SDR catch-up
*We operate as a support vendor under client SOPs and licenses. Regulatory filings are performed by the sponsor/CRO, or by us only when expressly authorized in writing.
Ready to Accelerate Your India Programs?
Let’s discuss how our FSP support can strengthen your study execution and quality outcomes.
Typical response: 24 hours