Reference material,
not marketing.
In-depth guides written by our regulatory, R&D, and QA teams. Every paper is delivered personally within one business day — no gates, no drip campaigns, no sales spam.
Current library
3 publications available. New titles quarterly.
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.
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.
Looking for something specific?
If you're evaluating a topic we haven't published on yet, drop us a line. Requests we hear repeatedly often turn into our next paper.