Development to filing
CMC strategy and regulatory support
A control strategy and a dossier that tell one consistent story, from first-in-human to marketing authorisation.
Discuss your programmeOverview
Reviewers read a CMC section looking for one thing: whether the company understands its own process. Gaps between what the data show, what the specifications claim and what the batch records do are where questions come from.
We work with your development, quality and regulatory teams to close those gaps before a health authority finds them, and to write the result in a form that is easy to review.
What we do
Module 3 authoring and review
We write or rework the quality sections for IND, IMPD, BLA and MAA submissions, and review drafts from your team or other consultants for consistency and completeness.
Specifications and control strategy
We link each critical quality attribute to its process controls and its limits, with a justification you can defend, using the principles in ICH Q6B and Q8 to Q11.
Comparability
When the process changes, we design the study that shows whether earlier clinical data still apply, following ICH Q5E, and write it up for the regulator.
Stability programmes
We set up phase-appropriate stability studies and build the shelf-life case as data accumulate.
Regulatory strategy and gap analysis
We compare your package with current guidance and your target pathway, then rank what needs doing before filing.
Meeting preparation
Questions, briefing packages and rehearsal for scientific advice, pre-IND and similar meetings, with a technical expert alongside your regulatory lead.
When teams call us
- You are preparing a first IND or IMPD and the CMC section is the longest open item.
- A process change is planned and you need to know whether clinical data will still bridge.
- A health authority has asked questions about your control strategy or specifications.
- A partner or acquirer is about to review your CMC package.
How it runs
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Review the evidence
We read your process descriptions, data and any previous correspondence, and list what is missing or inconsistent.
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Agree the strategy
We set out the filing approach, the risks and the studies needed, and agree priorities with you.
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Write and assemble
We draft sections with your subject matter experts and keep a single source of truth for every claim.
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Support the review
We help prepare responses to questions and join discussions where a technical voice is useful.
Common questions
Tell us what you are facing
A thirty-minute scoping call, no charge. We will tell you honestly whether we are the right team.