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Operant Scientific

Regulatory-first CDMO · Since 2016

Where regulatoryprecision meetsmolecular science.

API and intermediates manufacturing serving 20+ countries with 8+ years of clean regulatory inspections. WHO-GMP, MHRA-aligned, cGMP throughout.

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By the numbers

Eight years, zero critical
inspection observations.

0+
Years experience
Since 2016
0+
Countries served
APAC · LATAM · EMEA
0+
Molecules developed
Across 8 therapeutic areas
0%
Inspection pass rate
WHO-GMP + MHRA audits
Global reach

20+ markets.
One regulatory backbone.

From ANVISA in Brazil to the HSA in Singapore, we prepare market-specific dossiers and stand behind our chemistry at every inspection. Explore where we ship, who we've registered with, and the local partners on the ground.

Explore global presence

Featured case

42% lower process mass intensity on a European molecule.

A greenfield route scouting engagement for a European client's on-patent molecule. Six months from literature review to a validated three-step route that halved solvent usage and cleared regulatory review at the first attempt.

Molecule
Small-molecule NCE
Market
EU + UK
Timeline
6 months
Outcome
PMI −42%
Read the full caseRepresentative case — full attribution under NDA.
Trusted by

Pharma buyers on four continents.

Sample partners — real names available under NDA

APAlpha Pharma
NNordyx
ZBZenith Bio
MLMeridian Labs
ACAster Chem
CSCorvus Sciences
HHHelion Health
VAVireo API
PPentak
SBSolvay-affiliated buyer
KKlareon
FRFoundry Rx
Their route scouting team returned four viable options with real cost and PMI numbers, not just chemistry. That level of engineering discipline is rare in Indian CDMOs — and it's why we've stayed.
Regulatory Director· EU-based specialty pharmaName withheld under NDA. Full attribution provided on request.
Compliance

Ready for audit,
every quarter.

WHO-GMP
Reg. approved
MHRA
Aligned framework
ISO 9001
Quality mgmt
ICH Q7/Q9/Q10
Pharmaceutical quality
Ready to talk chemistry?

Talk to a subject-matter lead — not a gatekeeper.

Every enquiry lands with a regulatory, R&D, or manufacturing SME. NDAs signed within one business day for confidential molecules.

Chat with us