CDMO, UK
Acquisition, GMP Transformation and successful exit within 5 years
Overview
Client: a UK-based pharmaceutical CDMO specialising in drug substance, drug product, bioanalysis, and clinical manufacturing services for biotech and pharmaceutical companies.
I was initially engaged to support the rapid GMP and operational due diligence of a loss-making pharmaceutical site being acquired from a global pharma organisation. Following the successful acquisition, I continued supporting the business through its GMP transformation, operational scale-up, and regulatory expansion as it developed into a profitable stand-alone CDMO.
The business was successfully transformed and sold within five years of acquisition.
challenge
The initial acquisition phase required a rapid assessment of the site’s technical capability, GMP maturity, operational scalability, and commercial viability within an extremely compressed timeframe.
The site was operating under considerable uncertanty with a risk of closure
Accelerating business growth balanced with strenthening GMP systems
Rapidly increasing internal capability, maintaining existing operations
Expanding service offerings to meet global pharma and biotech expectations
APPROACH
I led the operational and GMP due diligence assessment, focusing on facilities, quality systems, infrastructure, operational capability, and workforce expertise. Following the acquisition, I designed and led a GMP and quality improvement programme to meet the owners’ growth strategy.
01
Conducted detailed GMP and operational gap assessments
02
Developed and implemented a phased GMP improvement programme
03
Supported MHRA inspection and approval readiness, expanding the QMS
04
Led the implementation of the Site Master File, Validation Master Plan, and Data Integrity Programme
05
Coached and transferred capability to internal teams to support long-term sustainability of improvements
Throughout the programme, I worked closely with site leadership and business owners to ensure operational improvements remained aligned with commercial growth objectives.
outcome
rapid assessment
Due diligence and operational/GMP assessment completed within 2 weeks
REGULATORY APPROVAL
MHRA approval for expanded GMP manufacturing capability and CDMO services
INCREASED CAPABILITY
Retaining and increasing revenues from global pharma and biotech customers
SUCCESSFUL EXIT
Turnaround, sale and integration of business to new owners within 5 years
Insight
Successful transformation in regulated environments depends on aligning commercial ambition, GMP capability, and organisational culture from acquisition through to exit.
UNDERSTOOD EXACTLY WHAT WE WERE TRYING TO BUILD
INVESTOR AND MANAGING DIRECTOR
“Having previously worked with Mark on projects including another CDMO transformation and exit, I already knew he could quickly understand both the commercial objectives and operational realities of a complex pharmaceutical business. He worked closely with our teams to implement a practical, scalable approach that helped position the business for long-term success and eventual exit.”