For a start up biotech in advance of its first filing, we conducted a Compliance Gap Assessment of its entire R&D group. Gaps were identified across key documents and processes. DArcy Consulting worked with the client to close identified gaps in areas such as Policies & SOP and training.
For a start up biotech company, we developed an entire suite of SOPs for Clinical, Regulatory, Pharmacovigilance and some Medical Affairs.
As part of an M&A for a pharma client, we coordinated and supported the transfer of all policies and SOPs to the acquiring company’s QMS. This included systematically going through all 2000+ documents to determine what would be kept for ongoing studies or retired.
For a company that had received a 483, we developed the business processes and documents to transform the Medical Writing Function – ultimately establishing a process for timely and efficient completion of the Clinical Study Report.