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Nutraceutical

Efficacious dose, stable through shelf life, compliant on the label.

Overview

Efficacious dose, stable through shelf life, compliant on the label.

Nutraceuticals sit between food and pharma, and are regulated as neither. We formulate to a defensible dose, validate stability of the active rather than the base, and build the label so that your claims survive a regulatory review and a competitor complaint.

Capabilities

What this practice covers

Formulation & dosage

Actives selected on evidence and permitted limits, with excipient systems that hold the dose.

Delivery format selection

Tablets, capsules, effervescents, gummies, sachets, powders and liquids chosen on stability and cost per dose.

Stability & assay

Accelerated and real-time stability with actual active assay, not just organoleptic checks.

Regulatory dossier

FSSAI Schedules, permitted ingredient lists, RDA limits and claim substantiation files.

Taste & compliance

Masking, granulation and palatability work so patients actually finish the course.

Manufacturing partner selection

GMP site evaluation, technology transfer and batch record review.

Inside the work

What a Nutraceutical project looks like

Formulation & dosage — Nutraceutical, Align Experts
Formulation & dosage
Delivery format selection — Nutraceutical, Align Experts
Delivery format selection
Stability & assay — Nutraceutical, Align Experts
Stability & assay
FAQ

Questions we get asked

Is a nutraceutical licence different from a normal FSSAI licence?

Yes. Health supplements and nutraceuticals fall under a specific regulation with its own permitted ingredient schedules and labelling requirements. We prepare the product against those schedules from day one.

Can you develop and also find a manufacturer?

Yes - development and GMP contract manufacturer selection are usually delivered as one project.

What is a realistic MOQ for a supplement launch?

Depending on format, 10,000 to 50,000 units. We help negotiate first-run quantities and plan a second batch before the first sells through.

Tell us what you are trying to make.

Send the brief, the sample or just the idea. You will speak to a consultant, not a call centre.