Senior Expertise Regulatory Affairs & Early phase Chemical Manufacturing Control Consultant
Helping teams navigate regulatory strategy, dossier preparation, and complex early CMC challenges with clarity and confidence.
Services
We offer a range of specialized services tailored to meet your individual needs. Our approach is focused on understanding and responding to what you require, providing effective and practical solutions.
Regulatory Strategy
Effective regulatory strategy is essential for transforming scientific innovation into successful, compliant, and timely product development. I support organisations in designing clear, evidence‑based regulatory pathways that anticipate challenges, reduce uncertainty, and accelerate progress toward clinical trials and marketing authorisation.
My service includes early gap identification, regulatory risk assessment, and the development of robust plans to request Scientific Advice meeting at EMA, pre‑IND at FDA, and pre‑submission interactions MAA at EMA. I help teams understand regulatory expectations, optimise development timelines, and ensure that documentation, study designs, CMC packages and MAA meet the standards required for global regulatory review.
Early Phase CMC Development
Early CMC development is critical for establishing the pharmaceutical foundation that supports safe, reliable, and compliant clinical progression. I help organisations design and implement early‑phase CMC strategies that ensure product quality (CMA,CPP,CQA), regulatory alignment, no clinical development and readiness for first‑in‑human and early clinical studies.
I provide expert guidance focuses on defining Core Quality Information (CQI), identifying development gaps, and building a clear roadmap that integrates formulation, analytical strategy, manufacturing considerations, and regulatory expectations. I support sponsors in navigating fragmented or evolving development programs, ensuring that early‑phase CMC packages are coherent, defensible, and aligned with EMA requirements.
Scientific-Regulatory Advisor
As a Scientific Advisor, I help organisations strengthen the scientific foundations of their development programs and ensure that every decision is supported by clear evidence, regulatory alignment, and strategic foresight.
I provide expert guidance across pharmaceutical development, ensuring that scientific rationales, study designs, and regulatory strategies are coherent, defensible, and supported by EMA scientific advice meeting it is required.
Scientific-Regulatory Advisor therefore sits at the intersection of biology MoA, early CMC, pharmacology, and pharmaceutical development, ensuring that the transition from preclinical research to human studies is scientifically coherent, technically sound, and fully aligned with regulatory expectations.
Professional services
We offer a range of specialized services tailored to meet your individual needs. Our approach is focused on understanding and responding to what you require, providing effective and practical solutions.
Regulatory and Early Phase CMC
Helping teams navigate regulatory strategy, dossier preparation, and complex early CMC challenges with clarity and confidence.
This is where our journey begins. Get to know our business and what we do, and how we're committed to quality and great service. Join us as we grow and succeed together. We're glad you're here to be a part of our story.
