Resources for Biotech Founders
The funding programs, regulatory agencies, and market access bodies we reference most often in our work and in our insights. All links go directly to the primary source.
Non-Dilutive Funding & Grants
Programs biotech founders in Europe and the UK most often use to extend runway without touching the cap table.
EIC Accelerator (European Innovation Council)
Grant up to €2.5M plus optional equity for companies moving from validated technology toward commercialization.
Horizon Europe
The EU's research and innovation framework program, including collaborative health cluster calls.
Innovate UK
UK grant funding and Smart Grants for early and scale-up stage life science innovation.
Bpifrance (i-Lab, Deeptech)
French public investment bank funding deeptech and biotech ventures through grants and innovation loans.
Eurostars (Eureka)
Funding for R&D-performing SMEs running collaborative cross-border projects.
Regulatory Agencies & Guidance
Primary sources for the requirements that shape IND-enabling, CMC, and clinical strategy.
FDA — Center for Drug Evaluation and Research
US guidance documents, pre-IND and formal meeting procedures, and submission requirements.
FDA — Center for Biologics Evaluation and Research (CBER)
Requirements for cell and gene therapies, vaccines, and other biologics.
EMA — European Medicines Agency
Scientific advice, PRIME, orphan designation, and EU marketing authorisation procedures.
MHRA — UK Medicines and Healthcare products Regulatory Agency
UK clinical trial authorisation, Innovative Licensing and Access Pathway, and post-Brexit routes.
ICH — International Council for Harmonisation
Quality, safety, and efficacy guidelines that underpin both FDA and EMA expectations.
EudraCT / CTIS — EU Clinical Trials Information System
The single EU entry point for clinical trial applications under the Clinical Trials Regulation.
ClinicalTrials.gov
Registry and results database for clinical studies worldwide — useful for competitive landscaping.
Health Technology Assessment & Market Access
Where pricing, reimbursement, and value evidence expectations are defined.
NICE (UK)
UK health technology appraisal, evidence requirements, and reimbursement decisions.
G-BA / IQWiG (Germany)
German benefit assessment and pricing negotiation framework for new medicines.
HAS (France)
French assessment of clinical benefit and added value for reimbursement.
EU Joint Clinical Assessment (HTA Regulation)
The EU-level joint clinical assessment framework now applying to new oncology and ATMP products.
Need help turning these into a plan?
Grant applications and agency interactions succeed on the strength of the regulatory and CMC story behind them. PXM supports founders on both.
Get notified when we publish new funding and regulatory guides
Practical guidance on FDA and EMA strategy, CMC readiness, and non-dilutive funding — sent only when there is something worth reading.