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
Trusted by Leading CROs & Sponsors Across India
- Pan-India Coverage
- Since 2010 Operating
- ICH-GCP Aligned
- FSP / vendor Engagement model
What we do
Four categories, four different regulators
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 of the programme is planning; settle it late and it is rework.
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.
- Initial submissions & acknowledgements
- Responses to queries & clarifications
- Protocol amendments & renewals
- Continuing review tracking
- Approval documentation & logs
Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
- IND/CTA dossiers & IMP import licenses
- DCGI approvals & clarifications
- Responses to deficiency letters
- Post-approval changes/variations
- Regulatory tracking & submissions
Pharmacovigilance Support
ICSR intake/processing, E2B checks, QC & medical review support per client safety SOPs.
- ICSR intake, triage & case processing
- Medical review & quality checks
- E2B(R3) & expedited reporting
- Signal detection & evaluation
- PSUR/DSUR & safety narratives
Clinical Data Management Support
EDC/eCRF build & validation, DMP/edit checks, coding, queries, freeze/lock support.
- EDC/eCRF design & validation (UAT)
- DMP, edit checks & listings
- Medical coding (MedDRA/WHO-Drug)
- Query management & data review
- Freeze & database lock
Biostatistics & Statistical Programming
SAP, SDTM/ADaM mapping, TLF programming & QC; submission-ready outputs.
- SAP & sample size/randomization
- SDTM/ADaM mapping & validation
- TLFs programming & QC
- ISS/ISE support & submission packs
- Ad-hoc/statistical consulting
Medical Writing
Protocol/IB, CSR, narratives and statistical sections aligned to TA context.
- Protocol & Investigator’s Brochure
- CSR & synopsis; patient narratives
- SAP & statistical sections
- Informed consent forms
- Safety aggregate contributions
Quality Assurance & Audits
Internal/vendor/site audits support, TMF health, deviation/CAPA tracking, inspection readiness.
- Internal, vendor & site audits
- TMF health checks & governance
- Deviation/CAPA lifecycle
- Inspection prep & escort
- SOP management & training
Clinical Trial Management Support
Program coordination from feasibility through closeout under client SOPs.
- Feasibility & site selection
- Start-Up (contracts, budgets, activation)
- Study initiation & oversight
- Risk/issue management & governance
- Closeout & archival
Site Management & Monitoring Support (CRA/CRC)
On-site/remote visit execution, SDV/SDR and follow-ups per the client monitoring plan.
- Monitoring plan, visit schedule
- SDV/SDR & follow-up letters
- Deviation & CAPA tracking
- RBM dashboards & risk signals
- Investigator support
Corporate Training & Workshops
In-house team training for sponsors, CROs and sites. Individual career courses are run by BCRI.
- GCP and GVP refreshers for study teams
- EC submission workshops
- Role-based upskilling: CRA/CRC, CDM, PV, Biostats/SAS
- Corporate programmes delivered on site or remotely
Why partner with us
Why Leading CROs Choose Prequel
Faster Activation
Parallel EC and contract workflows
Start-up steps run in parallel rather than in sequence, which is where most of the delay sits
Audit-Ready Quality
SOP-driven quality system
with SOP-driven QMS, TMF health checks, and inspection readiness
Clean Data On Time
RBM monitoring discipline
with RBM monitoring discipline and proactive data quality oversight
ICH-GCP & DCGI Aligned
Global standards
Operating within Schedule Y, CDSCO pathways, and ICH-GCP requirements
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
Client success
Case Highlights (FSP/Vendor Support): Challenge → Approach → Outcome
A few anonymized examples showing how our teams improved start-up speed, monitoring discipline, data quality, and submission readiness across India studies.
Oncology, Phase III — Faster Site Activation
- Challenge
- Slow EC/contract cycles delayed FPI.
- Approach
- Parallel EC dossiers & budget workflows; pre-init checklists.
- Outcome
- FPI in 29 days; visit adherence >95%; on-time DBL.
- 29 days First Patient In
- 95%+ Visit Adherence
- 100% On-Time DBL
Medical Device PMS — Safety Case Flow & Signal Hygiene
- Challenge
- Inconsistent ICSR triage and delayed follow-ups.
- Approach
- Unified intake; E2B(R3) checks; case QC and medical review gates.
- Outcome
- <24h expedited compliance; zero late cases over 2 quarters.
- <24h Expedited Compliance
- Zero Late Cases (2 quarters)
Rare Disease, Phase II — SAP → SDTM/ADaM → CSR
- Challenge
- Fragmented programming with unclear derivations.
- Approach
- Derivation specs; SDTM/ADaM map + double-programmed TLFs; parallel MW.
- Outcome
- Clean TLFs pass QC; CSR delivered on schedule.
- Pass TLF QC First Round
- On time CSR Delivery
Capabilities
Capabilities & Tools We Support (FSP/Vendor Model)
We work under sponsor/CRO SOPs and oversight. Our teams integrate with your validated environments to provide execution support across EDC/CDM, Pharmacovigilance, Biostatistics & Programming, TMF/CTMS, and Regulatory/EC coordination. Specific tool stacks are confirmed during onboarding and disclosed under NDA.
EDC
EDC & Clinical Data Management Support
We build and maintain study databases under client governance.
- eCRF design & edit checks
- DMP, UAT, listings & reconciliations
- MedDRA/WHO-Drug coding
- Query management & data review
- Freeze & database lock support
PV
Pharmacovigilance & Safety Support
Case processing and aggregate support aligned to client safety SOPs.
- ICSR intake, triage & case processing
- E2B(R3), expedited & follow-ups
- Medical review & QC gates
- Signal detection & evaluation
- PSUR/DSUR contributions
SAS
Biostatistics & Statistical Programming
Programming support inside your validated environment.
- SAP, sample size, randomization
- SDTM/ADaM mapping & validation
- TLFs programming & double programming
- ISS/ISE support & submission packs
- Ad-hoc statistical consulting
TMF
TMF & CTMS Support
Documentation governance and operational tracking under client QMS.
- TMF setup, filing plans & health checks
- Version control, metadata & QC
- CTMS visit scheduling & action tracking
- Inspection readiness support
- Archival coordination
REG
Regulatory Tracking & EC Coordination
Coordination support with sponsor/CRO as filer of record.
- Dossier preparation & trackers
- Responses to deficiency letters (drafting support)
- Protocol amendments & renewals
- Continuing review & approvals tracking
- Communication logs & documentation
*We operate under client SOPs and licenses. Vendor/tool names are shared during discovery and NDA.
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
- 01
Discovery & Tooling Fit
Protocol synopsis or portfolio view, SOP map, role mix, access pathways.
- 02
MSA / SOW & SLAs
Statement of Work with service catalogue, KPIs, and governance cadence.
- 03
Ramp & Knowledge Transfer
Access setup, sandbox/UAT, role shadowing, documentation handover.
- 04
Operate & Optimize
Monthly governance, KPI review, backlog grooming, and continuous improvement.
*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