Cerebro CMC supports companies involved in the development of pharmaceuticals and biopharmaceuticals. Our consultancy service is focussed on the CMC (chemistry, manufacturing and control) aspects that are a critical component of the overall drug development programme. We are experts in the development of production processes and analytical methods, offering technical and quality consulting, from process development through to GMP manufacturing. Whether your challenge is an entry to Phase 1 studies or the complexities of Phase 3 registration, we integrate into your in-house team to select and manage your outsourced activities.

Cerebro CMC’s consultants are experts in the technical, operational and quality elements required for the development of small molecule and biological drugs.

We deploy experts with either the breadth of skills to manage whole CMC programmes or with the depth of skills to dive deep into specific disciplines: analytical validation, process development, technology transfer, manufacturing, stability, formulation, quality management systems.

All of our consultants have many years of experience directing contract development and manufacturing organisations, gaining a strong understanding of the regulatory requirements for a successful CMC package”