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.
- Five-axis scoring template (cost / PMI / safety / IP / timeline)
- Worked example: 42% PMI reduction on a European molecule
- IP-freedom checklist and patent-landscape method
- How to avoid the yield-vs-scalability trap
Other whitepapers.
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.
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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