Program outlines

How programs are actually structured

Anonymised outlines of real engagement patterns. Each one describes the situation, how the program was set up and — most usefully — what specifically made the difference.

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Why there are no client names here

Sourcing arrangements, filing strategies and licensing terms are commercially sensitive. We publish the structure and the reasoning, and we name a client only with their written consent. If you want detail on a situation close to yours, ask — we can usually go much further in a conversation than we can in public.

FSOCommercial-stage generic manufacturerRegulated market supplyAdvanced intermediate

Removing a single-source dependency without changing the filing

The situation

The molecule was supplied from a single manufacturing site. The site performed well, but an interruption would have stopped a commercial product, and no alternative had been qualified because doing so competed with higher-priority internal work.

How the program was structured

Mapped the chain upstream and found the nominal alternative drew its key starting material from the same producer
Screened candidate sites on route, capacity and documentation status rather than price first
Ran an on-site audit at the preferred alternative and drove findings to closure before approval
Prepared the regulatory variation in parallel so the second source could actually be activated, not merely identified

What made the difference

The decisive step was mapping beyond the first tier. Two suppliers that looked independent on the approved-vendor list shared an upstream producer, so the original dual-sourcing plan would not have provided the protection it appeared to.

Catching documentation drift before an inspection did

The situation

Supplier documentation had been collected during onboarding and filed. Since then, one manufacturer had refined its route, a certificate had lapsed, and an analytical method had been updated without the change reaching the customer's quality system.

How the program was structured

Built a documentation register covering every supplier in scope, with review dates and owners
Compared the current manufacturing reality against what the filings assumed
Rewrote change-notification obligations into the quality agreements where they were absent or unenforceable
Set a monitoring cadence so expiry and version drift surface automatically

What made the difference

Treating documentation as a live register rather than an onboarding artefact. Every gap found had existed for months without anyone owning the question of whether it still matched reality.

Changing the filing route before the dossier was written

The situation

The team planned to file through the route they had used before, without testing it against their real launch plan. The intended launch covered a limited set of member states, not the whole Union.

How the program was structured

Mapped the intended launch sequence and commercial timeline against each available route
Ran a gap analysis to establish what the existing package supported and what it did not
Classified gaps as reformatting, new analysis or new studies, since only the last category drives real delay
Recommended a route matched to the territory list, with the trade-offs and the fallback position stated explicitly

What made the difference

Asking which countries the product would actually launch in before asking what the dossier should contain. Route selection was a strategic decision that was about to be made by default.

A licensing decision changed by a reimbursement screen

The situation

The asset had a credible clinical package and the therapeutic area was familiar to the licensee. Reimbursement feasibility had not been examined, and the deal was moving toward a term sheet.

How the program was structured

Established the comparator each target market's assessment body would expect
Compared that against the comparator actually used in the trial programme
Assessed the pricing environment, including the effect of imminent generic entry on the achievable price
Produced a market-by-market feasibility view rather than a single go or no-go

What made the difference

Separating the approval question from the reimbursement question. The asset was very likely approvable; whether payers in the target markets would fund it at a viable price was a different test on different evidence.

Describe a situation close to yours

Send the specifics and we will walk you through how a comparable program was structured — including what we would do differently now.

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