FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
Market Accelerator
From working prototype to approved product
Most products do not stall on the science. They stall between the science and the market — on a classification nobody confirmed, evidence generated against the wrong requirement, or six vendors who never spoke to each other. Prequel runs that middle stretch as one programme.
What this is for
A manufacturer with a finished device still has to determine its classification, decide which market to enter first, build a risk file, commission the right bench tests, work out whether clinical evidence is required, stand up a quality system, assemble a technical file, and answer an authority's questions — usually while running the rest of the business.
Each of those has a specialist available for hire. The difficulty is that they are normally hired separately, in sequence, and each one assumes decisions the previous one did not actually make. Rework at that scale is expensive, and it is nearly always discovered late.
Market Accelerator is the alternative: one roadmap, one point of accountability, and stage gates so you commit to the next phase only when the last one closed properly.
The programme
Eight stages, each ending in something you can act on
Stages run in sequence but you do not have to start at one. Most clients join where their gap is, and the readiness assessment tells them where that is.
- 01
R&D & readiness
Intended use, claims, target markets, classification hypothesis and gap assessment.
Typically joined here with: A working product or prototype and no confirmed regulatory route.
Output Readiness report and roadmap - 02
Design & risk
Design controls, risk management and evidence planning.
Output Risk file, V&V plan and traceability - 03
Verification & validation
Testing strategy and qualified laboratory coordination.
Output Test reports and V&V evidence - 04
Clinical evidence
Clinical strategy, protocol, sites and ethics committees, data and statistics.
Typically joined here with: A requirement for clinical data you have not run before.
Output Clinical evidence and study report - 05
Regulatory
India, US, EU and other target-market pathways.
Output Submission-ready regulatory package - 06
Manufacturing readiness
QMS, suppliers, production controls and scale-up readiness.
Output QMS and manufacturing readiness package - 07
Commercialisation
Market segmentation, claims, evidence communication, channels and launch readiness.
Output Launch and commercial package - 08
Post-market
Post-market surveillance, vigilance, PMCF and real-world evidence as applicable.
Output Post-market evidence plan
Scope, stated up front
What we deliver, and what we coordinate
Most consultancies leave this vague. We would rather you knew before the contract than after it, so here is the split.
Delivered by Prequel
Our own team, working to our SOPs.
- Regulatory strategy & classification Intended purpose, classification rationale and target-market pathway determination.
- Regulatory dossiers & submissions Dossier preparation, trackers and deficiency responses. Filings are made by the sponsor, or by us when expressly authorised in writing.
- Risk management (ISO 14971) Risk management plan and file, hazard analysis, and traceability from controls to evidence.
- Quality management system (ISO 13485) QMS gap assessment, process and document matrix, audit-readiness planning.
- Clinical evidence strategy Whether clinical evidence is required, endpoint and sample-size strategy, protocol and investigation design.
- Technical documentation & medical writing Technical files, clinical evaluation documentation, reports and submission narratives.
Coordinated by Prequel
We define scope, manage timelines and review quality; a named specialist partner performs the work.
- Clinical execution Sites, ethics committees, monitoring, data management and safety reporting, staffed against your protocol.
- Bench, performance & safety testing We build the testing strategy and standards matrix, then place and manage the work with qualified laboratories.
- Manufacturing readiness & supplier controls We define the readiness requirements and manage the specialists; production and supplier qualification sit with your manufacturer.
*Partner-delivered work is performed by named specialists under our scope, timeline and quality review. Partner identities are shared during discovery and under NDA. Regulatory filings are made by the sponsor, or by us only when expressly authorised in writing.
Target markets
Regulatory routes we work in
The right route depends on your device, its intended use and where you are going first. Each of these explains what the route requires.
AYUSH — ASU products
What licence does an Ayurvedic or herbal product need, and who issues it?
CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
510(k) — US FDA
Which predicate do I claim, and what evidence proves substantial equivalence?
De Novo — US FDA
There is no predicate for my device. What route is left?
PMA — US FDA
My device is high risk. What does a PMA actually demand?
EU MDR 2017/745
What does EU MDR require beyond what I already have?
ISO 13485
What does a device QMS need to contain, and are we audit ready?
ISO 14971
How do I connect hazards to controls, and controls to evidence?
Cosmetics — India
Do I need an import registration or a manufacturing licence — and who issues it?
NDCT 2019 — clinical trials
What approvals does a clinical trial in India need, and in what order?
BIS certification
Does my product need a BIS licence, and against which Indian Standard?
Commercials
Why coordination costs less than managing it yourself
This is a claim about how the work is organised, not a discount. The saving comes from not paying twice for the same thing.
One roadmap instead of several
Technical, regulatory, clinical, quality and commercial work planned together, so decisions in one do not invalidate work in another.
Gaps found before the invoice
Early gap assessment reduces the risk of commissioning tests or studies that do not support the intended pathway or claims.
No premature hiring
Modular resourcing means you do not build a full internal regulatory, clinical and quality team before you need one.
Evidence reused where permitted
Controlled documentation and traceability reduce repeated work across markets where reuse is allowed.
Stage gates before major spend
Each stage ends in a go / no-go decision, so commitment is staged rather than made up front.
*Cost-effectiveness here describes coordination and staged commitment. It is not a claim about absolute price, and it is not a substitute for a quotation.
How to start
Four ways to work with us
Most first engagements are a Readiness Assessment. It is deliberately small, and it tells you whether the rest is worth doing.
Start here
Readiness Assessment
Early-stage product or prototype
A low-commitment assessment that identifies the regulatory, evidence and execution gaps before you spend on testing or studies.
Managed Workstream
A defined regulatory, clinical, quality or evidence requirement
Dedicated cross-functional execution against clear milestones.
Market Accelerator
End-to-end transition from R&D to commercialisation
Coordinated technical, regulatory, clinical, manufacturing and commercial programme under a single point of accountability.
FSP / Functional Support
A CRO, SMO or sponsor needing additional capacity
An embedded functional team working under your SOPs and oversight — our established clinical research business.
Start with a Readiness Assessment
Tell us the product, the stage it has reached and the market you want. We will come back with where the gaps are and what closing them involves — before anyone commissions a test.
Typical response: 24 hours