Medical Affairs and Pharmacovigilance

Atran has the clinical expertice to support your company in the ever increasing regulatory requirements that has been laid on the pharmaceutical industry during the past years. We have experience in typical Medical Affairs functions such as acting as Medical Advisor and medical writing to the strict processes linked to  Pharmacovigilance. With a flexible approach, Atran can take the full responsibility or just be the missing link within your organisation. 

Clinical expertise 

 

The Atran team for Medical Affairs presents information on medicinal products in the form it needs to be done. It may be everything from clinical trial protocols or reports during the drug development stage to expert reports, medical statements or CTD modules 2.4 to 2.7 for Marketing Authorisation applications or variations.  

We have also the experience in acting as Medical Advisor or the role as Safety Physician which is linked to the Pharmacovigilance services. 

Safety first

Either you need a complete system for Pharmacovigilance to be able to take the full responsibility as MAH (including medical review, signal detection, roles of QPPV and Safety Physician, etc) or just need to have a local acting responsible PV role to act as local representative and managing local PV requirements. No matter, Atran can provide you with the service required. We have experience in full systems as MAH, including database management, but also acting locally such as reviewing local literature and forward local reports to centralized PV departments. Your requirements define they way we work. 

Our Services include

  • CTD Modules 2.4-2.7

  • OTC Switch

  • CSPs, CSRs, IB

  • Expert reports

  • Medical Advisor

  • QPPV and Safety Physician

  • PV SOP system

  • PV Literature search