Formal Engagements

Whether we come on-board before regulatory approval is granted, during or after this process, we can help you to navigate the uncertainties of getting your technology to patients.

Since 2015 P4A have been involved in a wide range of projects where clients have required Formal Engagements.

We work with a broad spectrum of clients; from large and mid-size Pharma to smaller Biotech clients. For over 5 years our team have successfully developed briefing materials and led productive engagements with regulatory and HTA organizations.

We are familiar with HTA & Regulatory bodies.
Some well-known organizations include:

How does a Formal Engagement work?

We hold preliminary discussions with you to ascertain your current situation and then advise the best route of action to optimize your chances of launching your asset.

Formal engagements are a long-term process, lasting 3-6 months which require careful planning and execution.

We provide end-to-end support throughout the process to ensure all outcomes are optimized to your situation.


Step 1

Briefing, logisitics, pack submission

  • P4A schedule a date on with the relevant HTA or Regulatory body and develop a briefing pack and question list
  • We confirm alignment and receive the client’s sign-off. We then collate the information in the formal body’s required format
  • P4A translate the brief into local language. We submit the briefing and question pack to the relevant body and await their response

Step 2

Alignment, translation, moderation

  • A meeting is held between the Client & P4A moderators to ensure final alignment on key topics during the engagement
  • Experienced local language speaking P4A moderator will represent the Client and moderate the discussion (if required)
  • P4A representatives will also additonally attend to take notes and ensure a comprehensive capture of the meeting

Step 3

Reporting, feedback, conclusion

  • Experienced consultants write-up notes from the meeting and share within a week of the formal engagement taking place
  • We also develop an accompanying report that outlines the key pieces of feedback from the meeting
  • Meet with client to share the report, align on key pieces of feedback from payers and identify gaps that need further investigation

Want to find more information about how MAXconnect can assist your journey?
Contact us

Read about how MAXconnect’s formal engagements helped a client to successfully launch.
Read Case Study