New combination product and medical device legislation increasingly focuses on safety, oversight and regulatory compliance. As more and more pharmaceutical companies include combination products or medical devices in their portfolio, the existing pharmaceutical governance models, processes and supporting databases are tested to their limits. This is becoming increasingly evident in regulatory inspection findings.
At Navitas Life Sciences, we believe that at least three initiatives are key:
- Proactive cross-functional governance and organisation
- Aligned drug and device processes
- Forward-looking UDI and IDMP integration