The 2026 global regulatory landscape for API manufacturers
APAC · LATAM · EMEA — a market-by-market playbook
A 32-page playbook covering the current regulatory requirements, dossier formats, and inspection expectations in 20+ markets where Indian CDMOs commonly supply. Includes decision trees for CTD vs eCTD vs ACTD, and a checklist for market-entry due diligence.
- Market-by-market dossier formats and typical review timelines
- Inspection-focus differences: MHRA vs WHO vs USDMF vs ANVISA
- Common findings and how to avoid them
- China+1 supply-chain considerations
Other whitepapers.
The route scouting scorecard: a repeatable methodology
Cost · PMI · Safety · IP freedom · Timeline
How we score two-to-three candidate routes at the end of every route scouting engagement — with worked examples from anonymised client work. Includes our five-axis scorecard template, a PMI baseline table, and an IP-freedom checklist.
Nitrosamine risk assessment: a practical guide for API manufacturers
ICH M7 + regional supplements, with worked examples
A practical guide to running a nitrosamine risk assessment under ICH M7 and regional supplements. Covers assessment scope, analytical strategy (LC-MS/MS), acceptance limits, and how to file a mitigation plan when a signal is found.
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