With experienced drug safety and medical writing teams, HPM is well positioned to prepare safety reports. The structure and content of safety aggregated reports has evolved over the years and we at HPM able to ensure that our work is well written, timely and in compliance with latest standards.
The documents we currently prepare include:
Periodic Safety Update Reports (PSURs): we have extensive experience preparing PSURs
Bridging Reports
Addendum Reports
Risk Management Plans (RMP): with proactivity in drug safety now obligatory, we have gained considerable experience in the preparation of RMPs.
Safety issue work-ups: our expert medical staff has a broad experience in the preparation of documents focused on one safety issue, summarizing all available information
Adhoc responses to health authorities
