CMC & Dossier Support

High-quality Chemistry, Manufacturing, and Controls (CMC) documentation is essential for regulatory approval and product integrity. Equinox offers specialist support to ensure dossiers meet global standards:

Preparation and critical review of CTD Module 3 (Quality), covering all dosage forms.

Expertise in sterile, modified-release, and complex formulations.

Lifecycle management, including updates to reflect manufacturing or process changes.

Compliance reviews to identify gaps and ensure regulatory readiness.

Guidance on global CMC requirements to support multi-region submissions.

Our practical, regulator-informed approach helps clients minimise deficiencies, maintain compliance, and achieve faster, smoother approvals.

Discover how we can support your next project