Knowledge Centre
Notes from the work, written for people who have to deliver it.
Short, practical pieces on the decisions that most often decide whether a launch date holds. Written in-house and dated, because requirements move.
Labelling
Design the label before you freeze the formula
Mandatory particulars, claim limits and language requirements are formulation constraints. Treating them as an artwork task at the end is where launch dates go missing.
6 min read · Read article →
Market entry
How to sequence launch markets so evidence compounds
Choosing a first market for its dossier reusability rather than its order size often shortens the path to the third and fourth markets.
8 min read · Read article →
Testing
A proportionate testing plan, not a laboratory shopping list
What a reviewer expects to see, what your specification requires, and what is simply nice to know — three different budgets.
5 min read · Read article →
Documentation
What a useful documentation gap analysis contains
A gap list without an owner, a format and a sequence is a worry list. Here is the structure we use instead.
7 min read · Read article →
Claims
Matching claim wording to the evidence you actually hold
Most claim problems are not fabrications; they are small escalations in wording that outrun the study behind them.
6 min read · Read article →
Compliance
The obligations that begin the day you launch
Renewals, change notifications, complaint handling and document retention: the maintenance calendar every file needs.
5 min read · Read article →
Middle East
Exporting to the Gulf: the documents that decide your timeline
Attestation, importer arrangements and Arabic label content usually govern the schedule more than the technical review does.
7 min read · Read article →
Ayurvedic & herbal
Taking ayurvedic and herbal products into export markets
Botanical identity, extract characterisation and heavy-metal parameters: what an overseas reviewer expects to see documented.
8 min read · Read article →
Nutraceuticals
How to structure a supplement dossier for multiple markets
A shared core with national annexes beats a stack of separate files — provided the core is built with that intent from the start.
6 min read · Read article →
Product development
Stability studies: planning shelf life you can defend
Shelf life is a claim like any other. Design the study around the pack, the market and the storage conditions you will print.
6 min read · Read article →
Quality
What to ask your contract manufacturer for, in writing
The document set that should exist before your first commercial batch — and who owns each item.
5 min read · Read article →
Technology
Where AI genuinely helps in regulatory work — and where it does not
Research speed and drafting support are real gains. Deciding whether a requirement applies is still analyst work.
6 min read · Read article →
Note
These summaries outline the articles we are publishing next. Nothing here is legal or regulatory advice for a specific product — treat it as orientation, and confirm the current position for your own file.
Have a question we should write about?
Send it over. The topics we publish come from questions clients keep asking.