Illustrative use case

CDMO product development coordination

Coordinating formulation, analytical and scale-up work across a CDMO and a separate testing laboratory.

CDMO R&D Illustrative use case

Challenge

Development and testing sat with different organisations, and decisions were slowed by unclear responsibilities.

One integrated plan, clear responsibilities and a single development record.

Set up a joint project plan, a RACI, a shared decision log and fortnightly technical reviews.

Each stage gate approved against agreed entry and exit criteria.

Expected benefit: faster decisions and a traceable development history.

This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.

R&D / Formulation

Structuring an immediate-release tablet development so trial data leads to a scalable, documented formulation.

Manufacturing / R&D

Reducing yield loss and in-process rejections in an oral solid dosage process.

Manufacturing / CMO

Finding and evaluating a qualified manufacturer for an oral solid product for a regulated market.