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.
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.
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.
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.
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 are governed under different legislation, with different evidence expectations and different definitions of what you may claim. It is rarely one authority per category either — a single device programme can involve CDSCO here, FDA in the United States and a notified body in Europe, each against its own framework. A consultancy that treats all of this as one offering has usually not read the second set of rules.
The categories do meet in one place: the boundary between them. A supplement claim that strays into treatment makes the product a drug. A cosmetic claim about repairing tissue does the same. Knowing where those lines sit, and pricing the consequence of crossing one, is most of the value in an early assessment.
That is a common and entirely reasonable position to be in — and it is the first thing a Readiness Assessment settles.
