Our Services

Interim programme management and CMC/CMC regulatory consultancy services

We provide interim programme management and CMC/CMC regulatory consultancy services to advanced therapy, biotechnology and pharmaceutical organisations at various stages of development. This includes working with client teams to manage CMC activities, advise on and support programme planning, and provide technical and regulatory input where additional resource or specialist expertise is required.

Examples have included multiple long term contracts supporting early phase AAV gene therapy companies with the development and implementation of their CMC and CMC regulatory strategies as well as providing expert technical advice on CMC activities. BioCMC have also provided programme management support to a start up gene therapy company, providing progamme leadership services for their lead programme

CMC technical and scientific expertise during company transitions

We provide CMC technical  expertise and leadership during company transitions, including acquisitions. We work alongside organisations during transitions to new management structures, helping to maintain continuity of key CMC activities and programme progression. This involves working with both existing and incoming teams to help ensure ongoing projects, documentation, and regulatory activities continue to progress during periods of organisational change.

Examples have included providing CMC leadership for a client’s lead programme during an acquisition and providing interim CMC leadership to a client during divestment of their manufacturing and CMC group.

Specialist expertise for the delivery of short-term projects

We provide targeted CMC consultancy to support short-term projects, working alongside client teams to address specific CMC or programme-related requirements. This expertise has been applied across a range of focused project activities.

Examples have included leading a CDMO selection process for a small start-up gene therapy company and providing advice and guidance on in-use stability studies for an oncolytic virus company.

Ad hoc consultancy and technical expertise for specific project requirements

We provide ad hoc consultancy and technical expertise to address specific project requirements, working collaboratively with organisations where targeted input is required within particular areas of CMC or programme activities.

Examples have included reviewing CMC regulatory documents and responding to CMC-related questions for a small gene therapy company.