Translating breakthrough science into approved medicines

Core Consulting Services

  • Regulatory Strategy: Your regulatory advisor to execute comprehensive regulatory strategies across clinical development, early‑stage CMC, CTA setup, and early marketing‑application interactions.

  • Early phase CMC development: Ensuring seamless alignment across non-clinical, clinical, and early CMC (Chemistry, Manufacturing, and Controls) development plans for your CTA (CTIs).

  • Scientific & Regulatory Advisory: Offering specialised strategic consulting, including EMA Scientific Advice (EMA SA), Paediatric Investigation Plan (PIP) development, and EMA pre-submission integration MAA.

Comprehensive development expertise

My Scientific Advice & Regulatory Affairs service bridges the critical gap between lab discovery and market access by integrating rigorous science, robust early‑phase CMC foundations, seamless clinical development, and proactive global regulatory pathways.

Professional Services

Regulatory Strategy

I provide executive regulatory guidance, delivering end‑to‑end strategies across clinical development, early‑stage CMC, CTA design, and initial marketing‑application engagement. I also navigate MHRA and EMA Scientific Advice procedures to strengthen your pre‑clinical development plan and accelerate your path toward first‑in‑human studies.

Early phase CMC Development

Supporting robust early-phase CMC foundations and analytical controls for biological, chemical, and cell or gene therapies.

Scientific-Regulatory Advisory

Using a structured compliance checklist, I perform a rigorous GAP analysis to identify scientific, regulatory, CMC, and clinical‑development risks early. This approach allows me to guide programs seamlessly from in vitro and in vivo development supported by a robust mechanism of action into early clinical trials with data‑driven milestone planning and realistic timelines.

Investor Feasibility 

Providing independent scientific due diligence and risk-adjusted technical assessments for life sciences investors.

Science-led advisory with strategic vision

Supporting developers of innovative chemical, biological, and advanced therapy medicinal products (ATMPs). By combining deep scientific expertise with hands-on regulatory experience across the UK, Europe, and international markets, I support teams make confident, de-risked development decisions that accelerate safe, successful outcomes.

Integrating data, science, and compliance

We believe the fastest path to clinic and commercialisation is built on uncompromised scientific rigor and early alignment with regulatory expectations. Our data-driven frameworks enable biopharma teams to mitigate manufacturing, quality, and clinical risks before they escalate.

Ready to de-risk your therapeutic Clinical Trial program?

Whether you require early-phase technical advisory, scientific due diligence for an upcoming investment, or strategic regulatory guidance for MHRA and EMA submissions, We are ready to partner with you.

Get in touch

Operating hub

D.Sc. Randolph Alonso Consulting
Kettering, United Kingdom
Supporting clients across the UK, Europe, and globally online.
Email: ralonsous@gmail.com