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Regulatory excellence
Regulatory strategy
Which route, in which markets, in what order, supported by what evidence — and confirmed with the right health authority at the right time.
Why it matters
The pathway decision is made early and is expensive to reverse
By the time a dossier is being assembled, most of the regulatory outcome has already been determined — by the pathway chosen, the questions asked at the right meetings, and the evidence designed to answer them.
Regulatory strategy is not a document produced at the end of development. It is a set of decisions taken early: which route, in which markets, in what order, supported by what evidence, and confirmed with which health authority interactions.
Those decisions interact. A choice made to accelerate a US filing can create a gap in the European dossier. A sequencing decision made for commercial reasons can leave a market unable to rely on an earlier approval. Our job is to make those trade-offs visible while they are still choices.
United States
FDA: getting the questions right before the money is spent
The formal meeting system is the most valuable and most under-used instrument in US development. A well-framed pre-IND question can save a repeated study; a poorly framed one wastes the only meeting you will get at that stage.
Meeting types and what they are for
| Type | Use it for | FDA replies | Meeting or WRO | Package due |
|---|---|---|---|---|
| INTERACT | Novel issues in early development where guidance does not yet exist. | 21 days | 75 days | With request |
| Type B | Milestone meetings, including pre-IND and pre-NDA/pre-BLA. | 21 days | 60 days | 30 days before |
| Type B (EOP) | End-of-phase meetings, typically after Phase 2 and before pivotal design is fixed. | 14 days | 70 days | 50 days before |
| Type C | Substantive discussion outside the defined milestones. | 21 days | 75 days | 47 days before |
| Type D | A narrow, well-defined question — typically no more than two topics. | 14 days | 50 days | With request |
| Type A | A stalled programme needing urgent resolution — clinical hold, dispute, special protocol. | 14 days | 30 days | With request |
Timelines reflect the PDUFA VII commitments for FY2023–2027. FDA may reclassify a request if the scope does not match the type asked for — which is itself a reason to have the questions reviewed before the request goes in.
Pre-IND: the meeting worth over-preparing for
A pre-IND meeting is a Type B meeting, and for most programmes it is the single highest-leverage regulatory interaction in early development. It is where the agency will tell you whether your non-clinical package supports the proposed first-in-human study, whether your proposed starting dose and escalation are acceptable, and whether the CMC information is sufficient for the phase.
What separates a productive pre-IND from a wasted one is question design. Broad questions invite broad answers. Specific, closed questions — with your proposed position stated and the supporting rationale attached — produce answers you can actually build a programme on. We draft, challenge and rehearse those questions before the briefing package is finalised.
From IND to application
An IND becomes effective 30 days after FDA receipt unless the agency places the study on clinical hold. That 30-day window is not a review to be passively awaited — it is the last point at which a gap identified internally can be addressed on your own terms.
On the application side, the route matters: a full new drug application under 505(b)(1), a 505(b)(2) relying in part on data the applicant did not generate, a biologics licence application under 351(a), or a biosimilar under 351(k). Each carries a different evidence burden, a different exclusivity position and a different set of risks. That choice belongs in the strategy, not in the submission planning.
European Union
EMA: advice early, procedure chosen deliberately
European development rewards engagement. Scientific advice is not a formality — it is the mechanism through which a development plan is tested against the assessors' expectations before those expectations become deficiencies.
Scientific advice and protocol assistance
Structured advice on quality, non-clinical and clinical development questions, with protocol assistance the equivalent route for orphan-designated products. Best used before a design is fixed, not after.
Choosing the procedure
Centralised, decentralised, mutual recognition or purely national. The choice is driven by product type, mandatory scope, market footprint and how the portfolio will be maintained afterwards.
Accelerated and supported routes
Where a product may qualify for enhanced early support or a shortened assessment, the eligibility case has to be built into the development plan rather than argued at submission.
Pre-submission planning
Rapporteur and co-rapporteur appointment, pre-submission meeting, and the practical sequencing that determines whether the dossier is ready when the slot arrives.
The MAA is a document set, but the assessment is a conversation
A centralised marketing authorisation application is assessed against a defined clock, with the clock stopping while the applicant responds to questions. Most timeline overruns in Europe are not caused by the assessment itself — they are caused by the length of the clock stops, which is under the applicant's control far more than it feels at the time.
Preparing for that means anticipating the question areas during dossier assembly, resourcing the response effort before the questions arrive, and having the internal decision-makers identified in advance. We plan the response phase as a workstream in its own right rather than as an afterthought.
Rest of world
WHO routes and reliance
Outside the US and EU, the strategic question is usually not "what does this authority require" but "what work can this authority rely on, and what do we have to do to make that reliance possible".
Prequalification
An assessment of quality, safety and efficacy against WHO standards, used by UN procurement agencies and by many national authorities as a basis for their own decisions.
Collaborative Registration Procedure
A route allowing national authorities to rely on a WHO prequalification assessment, or on an assessment by a stringent or WHO-listed authority, with a target national decision within 90 working days.
Recognition and abridged review
Many authorities now operate formal reliance pathways on named reference authorities. The saving is real, but it depends on submitting a dossier that matches what the reference authority approved.
Regional procedures
Regional and harmonised routes exist across several markets. Which are usable depends on product type and on whether the reference approval is in scope.
The practical constraint is consistency. Reliance routes work when the dossier submitted locally is demonstrably the same as the one the reference authority assessed. Divergence introduced for local convenience — a reformatted module, a locally amended label, an out-of-date certificate — is what most often removes a product from the fast route and puts it into a full national review.
What we do
How we work on strategy
Define the target
Markets, indications, timing and the commercial constraints that are actually fixed as opposed to assumed.
Map the routes
Available pathways per market, what each requires as evidence, and where one market's approval can be leveraged by another.
Find the gaps
Assess the current evidence base against each route and identify what is missing, what is weak and what is redundant.
Plan the interactions
Which meetings, in what order, with what questions. Question design is where most of the value is created.
Sequence and commit
An ordered plan with dependencies visible, so that a slip in one market has a known consequence elsewhere.
Hold it under change
Strategy that is not revisited when data or guidance changes becomes a plan nobody follows. We keep it current.
Bring us the challenge
Where are you in this, right now?
The most useful conversations start with the specific decision or deadline in front of you, not with a service category.