Turn a promising candidate into a product ready for the clinic
A candidate that performs well in the laboratory still needs a reliable path to manufacture. Production considerations are almost always the key rate-limiting factor in a clinical trial application, and therefore demand exceptional care, oversight, and planning. For biotech teams, this often means making critical CMC decisions with limited internal resources or experience, while managing specialist providers and preparing for regulatory scrutiny.
As part of your development plan our experts define the chemistry, manufacturing and control (CMC) tasks needed at each stage without overbuilding the programme too early. We will accompany you through each step of the CMC journey across manufacturing process development & scale-up, analytical methods development and validation, formulation development, stability studies and both non-GMP and GMP manufacturing.
You gain a practical CMC strategy, clear oversight of external providers, and documentation that is ready to support your clinical trial application.
CMC support
shaped around your next milestone
CMC strategy and planning
As part of your development plan, our team of expert drug developers define an integrated CMC strategy tailored to your product, intended clinical use and regulatory pathway, with timelines and dependencies.
Your plan will outline the whole CMC process including:
- Drug substance and drug product manufacturing process development & scale-up
- Analytical methods development & validation
- Potency assays (if required)
- Formulation development
- Stability studies
- Non-GMP and GMP manufacturing
- Clinical supply requirement planning
Our experts review the CMC aspects of existing development plans and ongoing studies, identify gaps and help you address them. Support can also be provided for specific tasks and problem-solving as challenges arise.
CDMO selection
RFP preparation
Our expert drug developers will generate clear, detailed requests for proposals, so CDMOs can respond accurately to your requirements.
CDMO identification
Our team will draw up an impartial list of appropriate CDMOs for both the drug substance and drug product manufacture.
Proposal review
We will liaise with each CDMO to obtain complete, optimal, and comparable proposals, together with costings to support informed selection.
CDMO audit
Our QA team can carry out GMP qualification audits of the selected CDMOs to ensure full compliance.
CDMO management
Our experts assess each proposed product development study to support optimisation and regulatory compliance. Working closely with your CDMOs, they monitor progress and results, identify problems early and help develop regulatory-compliant solutions that keep your project moving. Protocols, reports and manufacturing documentation are also critically reviewed for accuracy, consistency and regulatory compliance.
CMC oversight
CDMO coordination
We coordinate within and between the different CDMOs, keeping responsibilities, deliverables, and expectations clearly aligned.
CDMO coordination
Progress oversight
Our team monitor progress, keeping a close eye on timelines, budget, and risks, making emerging issues visible and delivering solutions before they delay delivery.
Progress oversight
Leadership reporting
Our experts will provide clear progress updates, giving your leadership team and board the information needed to make timely decisions.
Leadership reporting
CMC decisions need experienced developers behind them
You work directly with senior developers who challenge assumptions, guide CDMO advancement, and keep the programme focused on the milestone ahead.