From Formulation Brief to Validated Batch — in 4–6 Weeks

Vitamin potency is measured by HPLC (High Performance Liquid Chromatography) — the gold-standard method for quantitative vitamin analysis in complex matrices. Fat-soluble vitamins (A, D, E, K) and water-soluble B vitamins are each analysed using validated HPLC methods aligned to AOAC, USP, and in-house validated SOPs. Results are traceable to NABL-accredited reference standards. We do not rely on spectrophotometric screening as a sole potency method for vitamins where HPLC delivers greater specificity.

Accelerated stability studies run at 40°C / 75% RH (ICH Zone IVb conditions, aligned to Indian and tropical market requirements) with pull-point testing at 0, 1, 3, 6, 9, and 12 months. A 12-month accelerated study is typically completed within 12 months (run in parallel with commercial supply). Real-time studies run concurrently to build the full shelf-life dataset. You receive a stability summary report covering vitamin degradation curves, re-test date assignments, and label claim confirmations at each pull point.

Every commercial batch CoA covers: vitamin potency (HPLC), mineral content (ICP-MS or ICP-OES), heavy metal screening (arsenic, lead, cadmium, mercury) against applicable food safety limits, microbiological safety (total viable count, yeast & mould, Salmonella, E. coli), and physical parameters (moisture, particle size, bulk density). The CoA is issued by a NABL-accredited third-party laboratory and carries the laboratory's accreditation number — not an in-house document.

Yes. We prepare a full regulatory documentation package with every new formulation — including the formulation specification sheet, ingredient permissibility declarations, CoA data, stability study summary, and label claim substantiation. This package is designed to support FSSAI product registration, EU Novel Food and Food Supplement submissions, ASEAN food regulatory filings, and WHO/UNICEF procurement pre-qualification. We have experience preparing documentation for both Indian domestic registration and export regulatory filings.

We welcome client quality audits and pre-qualification visits. A standard audit agenda covers: facility tour (Human Nutrition and Animal Nutrition zones, analytical laboratory, stability chambers, raw material store), document review (batch manufacturing records, cleaning validation logs, out-of-specification investigation reports, calibration records), and a Q&A session with our Quality Manager. We provide a pre-audit documentation pack to qualified buyers on request — so your team can review our quality system before the visit.

Yes. New product development begins with a formulation brief from you — covering target nutrients, food vehicle or dosage form, regulatory market, desired shelf life, and any processing constraints. Our R&D team translates that brief into an initial formulation design, selects appropriate ingredient forms, runs a prototype batch, and delivers a validated specification sheet and CoA data within 4–6 weeks of receiving the completed brief. We iterate with you on the prototype until the formulation meets your requirements before scaling to commercial production.