We are often asked if we advise biotech companies. Absolutely – we advise biotech companies, but not in the narrow sense of offering ad hoc opinions.
Our advisory role is embedded directly into how we lead and manage complete CMC drug development programs. Our work goes far beyond traditional consulting, as we typically step in as a strategic and operational CMC partner, guiding programs from early development through clinical readiness. That includes defining the CMC strategy, selecting and managing CDMOs, anticipating regulatory expectations, and ensuring that every technical and operational decision aligns with the long term clinical and commercial plan.
Leveraging our proven expertise in chemistry and Active Pharmaceutical Ingredient (API) manufacturing, CMC‑Rx Consultancy oversees the full spectrum of CMC activities for both drug substance and drug product development. We support virtual biotech companies that require seasoned chemistry leadership to advance their development programs with confidence and compliance.
Our technical support services span the full analytical and CMC landscape, including impurity and degradation‑product identification, NMR data interpretation, batch record review, assessment of potential (geno)toxic impurities, physico‑ chemical characterization of drug substances and drug products, analytical data evaluation, and preparation of clear, decision‑ ready summary reports.
We prepare comprehensive Chemistry, Manufacturing and Controls (CMC) sections for regulatory submissions, including Module 3 of the Common Technical Document for IND applications. We also support our clients in developing the CMC components of Pre‑IND meeting requests and regulatory briefing packages, ensuring clear, well‑structured, and regulator‑ ready documentation.
We are frequently engaged by Investment Banks and Private Equity groups to conduct CMC Due Diligence on drug development programs they are considering acquiring or divesting.
Our role is to identify technical, regulatory, and operational risks — from manufacturability gaps to stability liabilities and scale‑up challenges — that could delay approval timelines or impact valuation.
We bring a pragmatic, scenario‑based approach that helps investors understand where hidden risks may lie and how they can be mitigated.