Post–M&A PharmaLex program governance

Start-up Pharma company with no REG, PV, Quality infrastructure with urgent need for Programme Governance to be established

• Major pharma portfolio asset purchase (approx. 20 products and 450 MAs, across 47 markets) .
• No ability to support program governance of multi-functional Regulatory Affairs (RA), Pharmacovigilance (PV) and Quality Management (QM) operational activities
• Required urgent support to provide operational activities and oversight, with the ability to establish an appropriate program governance model as required for a Pharmaceutical company.