Integrated MS&T, CMC and Regulatory support to manage change, maintain compliance, and move development and manufacturing forward with confidence.

TDP supports Chemistry, Manufacturing & Controls (CMC), Manufacturing Science & Technology (MS&T), and Regulatory Affairs activities through a trusted global network of specialist partners and consultants. This flexible delivery model enables organisations to access deep technical, scientific, and regulatory expertise precisely aligned to product type, lifecycle stage, and development strategy, without the need to build or retain large internal teams or to address decreet and highly nuanced and highly specialist aspects of a products lifecycle.

Our services span early development through to commercialisation, ensuring that technical strategies are scientifically robust, manufacturable at scale, and fully aligned with regulatory expectations across global markets. By integrating CMC, MS&T, and Regulatory Affairs considerations from the outset, TDP helps organisations reduce development risk, avoid costly downstream issues, and support efficient, successful regulatory approvals.

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CMC, MS&T & Regulatory
Affairs Consulting

BEST FOR

Tech transfer, scale-up, process change, or manufacturing readiness

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CMC strategy, documentation, and regulatory interface support

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Teams needing senior guidance across development-to-manufacture transitions

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WHAT’S INCLUDED

MS&T support across development, scale-up, and tech transfer

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CMC strategy and documentation support (scope-led)

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Regulatory input for CMC-related change and submissions

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Risk assessments, comparability thinking, and control strategy support

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Cross-functional coordination (QA, manufacturing, supply chain, RA)

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Clear deliverables and written rationale for key decisions

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Practical next steps and implementation support

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HOW IT WORKS

Align on objectives (programme stage, constraints, timelines)

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Define scope, deliverables, and governance

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Delivery with clear outputs and decision trails

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Handover, closeout, or ongoing support

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