Pharmacovigilance

Never once in all of our years in the industry have we forgotten that drug development is first and foremost about people–improving their health…and keeping them safe in the process. aktaPD®’s global safety and pharmacovigilance team includes knowledgeable, trained clinicians and nurses, expert in providing comprehensive pharmacovigilance service and post-marketing safety surveillance. Our team has a robust skill set in the changing regulatory arena and provides call center services, pre-approval SAE management, post-marketing AE/SAE management, product complaint/defect reports, post-marketing medical information, global ICSR and aggregate report regulatory authority submissions, literature review, aggregate report development and reporting, and, of course, direct patient care.

 

Want an expert partner committed to patient safety and study success? Contact us.