Strategic Situations | Biopharma Case Studies

We are always
on the move

Strategic Situations

Examples of the strategic, regulatory, and governance situations we have navigated with clients. All situations are confidential. Company names and identifying details are not disclosed.

We are always
on the move

Strategic Situations

Examples of the strategic, regulatory, and governance situations we have navigated with clients. All situations are confidential. Company names and identifying details are not disclosed.

Strategic Situation 01

Rare Disease Programme: EU Regulatory Pathway Strategy

A clinical-stage biopharma entering Phase II for a rare disease indication required a strategic assessment of the EU regulatory pathway, including orphan designation potential, accelerated pathway eligibility, scientific advice strategy, and long-term positioning toward EU registration.

Strategic Situation 02

Leading a Global BLA and EU MAA Programme Through Submission ReadinessInterim

A clinical-stage company preparing for its first filing lacked a dedicated regulatory function. With a submission timeline in place and multiple functions needing alignment, experienced regulatory leadership was required to develop the filing strategy and lead the cross-functional team through submission.

Strategic Situation 03

Parallel International Registration: Access Consortium or Project Orbis Strategy

A US-based biopharma with a product addressing a high unmet medical need sought to maximise speed-to-market by filing for registration in multiple countries simultaneously through an international parallel submission programme. The company required strategic guidance on feasibility, programme selection, and regulatory execution across jurisdictions.

Strategic Situation 04

Preserving Asset Value Through EU Orphan Designation and SME Strategy for a US Biopharma

A US-based biopharma establishing its European presence required strategic guidance on EU orphan designation filing, SME status optimisation, and submission infrastructure for EU regulatory engagement. The company needed both strategic regulatory advice and practical support in establishing its European regulatory presence.

Strategic Situation 05

Combination Product Strategy: Article 117 and Notified Body Alignment

A company developing an integral drug-device combination product was preparing for EU marketing authorisation. Article 117 device constituent requirements had not been fully integrated into the MAA planning timeline. With Notified Body review estimated at 6–9 months, the NB workstream risked becoming a critical path issue for the submission, with direct implications for filing timeline and programme value.

Strategic Situation 06

Navigating European Regulatory and HTA Requirements Amid Financial Headwinds

A clinical-stage company developing a medicinal product for the European market required a regulatory submission strategy alongside a strategic HTA roadmap and execution framework for Europe. Financial headwinds delayed HTA activities, creating a material sequencing risk for the European development programme.