Questions procurement,
regulatory, and R&D teams actually ask us.

Operant Scientific is an India-based CDMO (Contract Development and Manufacturing Organization) specialising in Active Pharmaceutical Ingredients (APIs) and intermediates. We take a molecule from route scouting through analytical development, scale-up, and cGMP manufacture — end to end.

We supply into 20+ countries across Asia-Pacific, LATAM, the Middle East, Africa, and CIS. Our regulatory dossiers are prepared with WHO-GMP and MHRA frameworks; we tailor per-market registration packs (CTD, eCTD, ACTD) to each jurisdiction.

The Operant Scientific team has been active since 2016, incorporated as a Private Limited entity in 2021. Every year since the first WHO-GMP audit we've maintained a clean inspection record.

Small-molecule APIs and their intermediates across a range of therapeutic areas. Our chemistry capabilities include multi-step synthesis, hydrogenation, cryogenic reactions, and typical unit operations up to 500L pilot and multi-tonne commercial scale.

Yes. Clients engage us at any point on the maturity curve — early-stage route scouting, pilot-scale campaigns, tech transfer, or steady-state commercial supply. We publish a capabilities deck on request that maps each stage to specific equipment and headcount.

MOQ depends on the molecule, its regulatory status, and downstream packaging. For validated commercial APIs we can typically support pilot campaigns from 10-50 kg; commercial batches are quoted per molecule.

Our manufacturing facility operates under WHO-GMP and MHRA frameworks with alignment to ICH Q7, Q9, and Q10. We regularly host client-led audits and third-party regulatory inspections; historical inspection reports are shared under NDA on request.

Yes — our Regulatory Affairs team prepares full CTD/eCTD/ACTD dossiers, DMF/CEP filings where applicable, and market-specific documentation (e.g. CoPP, Free Sale Certificate). We work with local partners in markets that require in-country agents.

Every deviation, OOS, or OOT triggers a formal investigation under our SOP framework, with root-cause analysis (typically 5-Why or fishbone), CAPA definition, and effectiveness verification. Clients receive full transparency on any event affecting their material.

Yes. A typical route scouting engagement runs 8-14 weeks and delivers 2-3 viable synthetic routes with a comparative scorecard (cost, PMI, safety, IP freedom). We publish a full literature review and lab-verified proof of concept for the recommended route.

Method development, validation to ICH Q2(R2), and transfer to a client's QC lab are core services. Analytical instrument coverage includes HPLC, GC, GC-MS, LC-MS, NMR, XRPD, DSC/TGA, and Karl Fischer.

Full ICH-compliant stability chambers cover 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, and photostability per ICH Q1B. Studies are executed under our QA-approved protocols with the option for client-signed data sharing at each pull point.

Send a brief RFQ or non-confidential enquiry via the contact form. For confidential molecules, we execute a mutual NDA within one business day, after which our BD lead scopes a technical call with the right subject-matter experts.

Development work is quoted on a milestone basis (route scouting, method dev, stability, tech transfer). Commercial API supply is priced per kilogram against a validated route and annualized volume commitment. We do not use per-hour billing.

All engagements start with a mutual NDA. For jointly developed IP, ownership terms are set in the master services agreement — we default to client-owned process IP for work paid on a fee-for-service basis.