Some examples of regulatory project management projects we've managed:
- Building project management organizations in regulatory
- Implementing tools to help regulatory groups better understand their workload and impacts on workload from things like label changes, acquisitions, etc.
- Managing NDA Submissions
- Integrating regulatory project management with drug development project managers
- Digital health strategies and regulatory approvals for digital medicine
- CMC impacts on drug development plans
Project management in regulatory has been lacking for years. As part of the DIA project management committee, we often had requests for presentations on how pharmaceutical companies are instilling better project management discipline into their regulatory processes. This is still an acute problem in the industry. As a result of this, Pharmica continues to add value to regulatory by providing the services listed below and other services.
These days regulatory functions are no longer a stand-alone function that waits at the end of a process to quickly assemble documents for submissions. Different strategies and planning are needed. Cross-functional input and impacts must be understood globally. This is typically not accomplished by promoting a successful publisher to become the next rock star regulatory project manager. It’s a different skill set and a cultural change. But don’t worry, Pharmica has decades of experiences to help you through this change.
"Our Pharmica consultants continue to provide that extra support that is a tremendous help to the team. They are doing an excellent job and it is much appreciated."
Vice President, Clinical Safety & Pharmacovigilance