Mission
Deliver regulatory-ready APIs and intermediates to speciality pharma companies who cannot afford a failed inspection.
About Operant Scientific
Regulatory precision.Scientific depth.Global reach.
Since 2016, Operant Scientific has been building an Indian CDMO that European and North American procurement teams choose specifically because we don't cut corners on regulatory work.
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Founded
Rajasthan, India
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Countries
APAC · LATAM · EMEA
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Molecules
Across 8 areas
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Inspections
Pass rate, 8 yrs
Who we are
A CDMO built for regulators first.
Operant Scientific Private Limited is an Indian pharmaceutical research and manufacturing company specialising in Active Pharmaceutical Ingredients (APIs), intermediates, and CDMO/CMO services. Since 2016 we have shipped into 20+ countries under WHO-GMP and MHRA-aligned frameworks, with a clean inspection record every year since our first audit.
We're a chemistry-first team. Our directors are on the plant floor, our QA leads sign every batch record, and our regulatory affairs group prepares each market's dossier in-house rather than outsourcing it. That's how we keep answers short during audits and turnarounds fast during tech transfer.
Our clients are speciality pharma companies in Europe, North America, and Asia-Pacific who need an Indian supplier that treats regulatory work as an engineering discipline, not a checklist. If that's what you're evaluating, you're reading the right page.
Vision
The default Indian CDMO on European and North American procurement scorecards — chosen for engineering, not price.
Purpose
Build the process discipline that raises the credibility of Indian CDMOs as a whole.
Values
Five principles we hold ourselves to.
Not generic mission statements. Specific behaviours we practice every day — and that clients can hold us to.
01
Chemistry first
Every recommendation is grounded in lab-verified chemistry, not marketing.
02
Audit-ready always
Documentation is complete at each shift change, not before the inspector lands.
03
Own the deviation
We report our own deviations before you find them. Speed matters more than optics.
04
Signed batch records
QA signs. Not delegated. Not automated. Human-in-the-loop on every batch.
05
Client-owned IP
On fee-for-service work, process IP is yours. Full stop.
The journey
Eight years, tracked to milestone.
2016
Founded in Pali, Rajasthan
Operant Scientific begins as a chemistry-led practice with a small team from India's academic and pharma sector.
2018
First international dossier accepted
Regulatory submission accepted by an Asia-Pacific health authority, establishing our credibility for cross-border supply.
2020
Ten-country supply footprint
Distribution partners active in APAC, LATAM, and the Middle East. First tonne-scale API campaign completed on schedule.
2021
Incorporated as Private Limited
Formal transition from partnership to Pvt. Ltd. establishes corporate governance, board structure, and long-term scale plan.
2022
Manufacturing scale-up
Multi-tonne API production comes online with dedicated QC lab and stability chambers meeting ICH Q1B.
2024
20-country milestone
Twentieth country registration cleared. Vendor onboarding portal launches for supplier-side WHO cGMP screening.
2026
Route scouting practice matured
Dedicated route scouting group runs concurrent programmes for European speciality pharma, cutting PMI on multiple molecules.
Regulatory postureReady for audit.
Ready for audit.
Every day.
Our compliance framework is anchored to WHO-GMP and aligned to MHRA expectations. Every dossier we submit is prepared by an in-house team that has sat across the table from EU and Asia-Pacific inspectors.
WHO-GMP
Reg. approved
MHRA aligned
UK framework
cGMP
Current GMP
ISO 9001
Quality mgmt
ICH Q7
GMP for APIs
ICH Q9/Q10
Quality risk + system
Sustainability
Not a story. A scorecard.
We publish measurable sustainability KPIs and update them annually. Below is the current baseline — the full report is available on request.
Environmental stewardship
Solvent recovery, closed-loop water systems, and green-chemistry alternatives evaluated on every new route.
Solvent recovery rate82%
Community impact
Local hiring, apprenticeships, and healthcare initiatives in and around Pali. We hire chemists from Rajasthan universities.
Local workforce78%
Ethical practice
Zero-tolerance code of conduct, independent whistle-blower channel, and transparent supplier due-diligence.
Compliance training100%
Leadership
Meet the team on the plant floor.
Our directors and department heads run this business hands-on. Meet them, read their credentials, and see the publications behind the decisions.
Ready when you are
Ready for a technical call?
Non-confidential enquiries answered within four business hours. Confidential ones under NDA within one business day.