CMC Support and Management

Team specializations:

Process development
Process validation
Drug Substance
Drug Product
Product Release and characterisation

Our team of experts is specialized in various critical areas to support your product development, especially for biological products (mAbs, cell and gene therapy products, exosomes... ) We work with biotech companies at various stages of their projects: Starting from early phases to Phase 3 and marketing authorisation application preparation.

Our scope of work:

Global development strategy

Early-stage strategy: process development, clinical batches, stability studies, planning, budget…

Late-stage strategy: comparability, process validation...

CMO/CDMO selection

Using structured frameworks and evaluation tools, assisting in Request for Proposal (RFP) creation and follow-up.

Project management

CMC engineering and technical support

Acting as CMC project manager for our client: process and analytical methods development and /or transfer, production, testing and quality event follow-up

Validation Plan

Providing technical support to clients with in-house labs, offering guidance on upstream and downstream processes.

Creation of accurate plans to ensure process validation, reproducibility and adherence to regulatory standards.