PSUR and PBRER Drafting: GPLACO Drug Safety and PV Consulting services on Aggregate Safety Reports for Global Markets: US, EU & UK

Effective PSUR and PBRER Drafting is essential for maintaining a product’s marketing authorization. These aggregate reports provide a high-level medical analysis of the drug’s safety and efficacy.

Common Challenges in Aggregate Reporting:

• Data lock point – Drafting and quality review with the DLP
• Submissions within timelines 
• Health authority enquires
• Quality

The biggest challenge in PSUR and PBRER Drafting is ensuring that data from all global sources (US, EU, APAC) is analyzed within the tight submission windows requires world-class Quality management.

As a Strategic Partner, we assist MAHs in streamlining their PSUR and PBRER Drafting to ensure 100% submission compliance.

Watch our video on PSUR and PBRER for more details: https://youtu.be/FdQl0Xk4Awk

Have a look at our service page on how we address the challenges and Connect with us for inquiries – Contactus@globalplacosolutions.com