Strategic Biopharma Advisory

Every programme begins with uncertainty. We help shape the path forward.

Supporting Boards, CEOs, founders, investors, and biopharma leadership teams in value-critical development, regulatory, and governance decisions across Europe and global biopharma environments.

We give shape and formSupporting boards, executives, and investors on value-critical development, regulatory, and governance decisions across Europe and global healthcare environments.

therainnova AG operates at the intersection of regulatory strategy, governance, integrated development, and innovation, advising boards, executives, founders, leadership teams and investors on decisions that determine asset value, development prioritisation, partnering readiness, financing strategy, and long-term competitive positioning.

therainnova AG operates at the intersection of regulatory strategy, governance, integrated development, and innovation - advising leadership teams and boards at the decisions that determine asset value, development timelines, and long-term competitive positioning.

Services

Strategic
Advice

Interim Management

Partnership

Submission
Management

Advisory Areas

What we do

We are providing a wide range of services in regulatory affairs both from an operational and strategic perspective.

Advisory Areas

Strategic Biopharma Advisory

Value-critical regulatory, portfolio, and governance decisions across biopharma environments. Influencing asset value, partnering readiness, and development risk.

Board & Executive Advisory

Strategic sparring for boards, CEOs, founders, investors, and biopharma leadership teams navigating complexity and governance risk.

Integrated Development & Portfolio Strategy

Regulatory, CMC, (non-)clinical, HTA, and development strategy for high-impact asset decisions influencing development risk, investor confidence, and future market access.

AI & Innovation in Regulated Biopharma

Strategic perspectives on the responsible integration of AI in regulated biopharma environments.

Advisory Workshops

A focused session to pressure-test a specific strategic, regulatory, or governance question with senior independent perspectives.

Why It
Matters

In regulated biopharma environments, regulatory, development, HTA, governance, and portfolio decisions directly influence:

Development risk and programme timeline

Investor confidence and financing readiness

Partnering and licensing optionality

Market access strategy and future revenue positioning

Long-term asset value

therainnova supports boards, investors, and leadership teams at these value-critical inflection points - across the full biopharma lifecycle.

Who We Work With

Biopharma leadership teams

Boards, founders, investors, and C-suite leaders

Investors and due diligence teams

Founders and CEOs navigating complex development decisions

Innovation-driven biopharma organisations

Strategic Situations

Rare Disease Programme: EU Regulatory Pathway Strategy

Strategic Situation 01

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 Situations

Leading a Global BLA and EU MAA Programme Through Submission Readiness

Strategic Situation 02

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 Situations

Parallel International Registration: Access Consortium or Project Orbis Strategy

Strategic Situation 03

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 Situations

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

Strategic Situation 04

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 Situations

Combination Product Strategy: Article 117 and Notified Body Alignment

Strategic Situation 05

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 Situations

Navigating European Regulatory and HTA Requirements Amid Financial Headwinds

Strategic Situation 06

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.

Strategic Situation 01

Rare Disease Programme: EU Regulatory Pathway Strategy

Strategic Situation 02

Leading a Global BLA and EU MAA Programme Through Submission Readiness

Strategic Situation 03

Parallel International Registration: Access Consortium or Project Orbis Strategy

Strategic Situation 04

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

Strategic Situation 05

Combination Product Strategy: Article 117 and Notified Body Alignment

Strategic Situation 06

Navigating European Regulatory and HTA Requirements Amid Financial Headwinds