Case Study Full service Post-Marketing Pharmacovigilance and Medical Information Services for large nutritional health company On behalf of {our company}, I want to say a big THANK YOU for all your support on this. Your lead and courage were fundamental for the success of this project. Please share my comments with the whole PharmaLex team as well for all their efforts to make this happen. - Head of US Regulatory Affairs

Challenge Solution Outcome Rapid set up and go live for PV Provision end-to-end PV services Timely provision of services and Med Info Services tailored to company’s needs ensuring compliance with regulatory requirements

• Large nutritional health company with newly • Thorough analysis of the company’s individual • Successful go-live: on time, comprehensive acquired Rx products in US and Canada required situation and needs system with fully trained team urgent full support with all PV activities, Medical • Setup of a global PharmaLex team with PV • End-to-end PV services provided by PharmaLex, Information contact center services, as well as experts both in the US and Europe, with a including medical information call center data migration of cases from prior MAH single point of contact overseeing all activities • Database set up for medical information and case • New to prescription drug market with 3-week • Critical timelines met to ensure set up of processing, including PV case migration timeline to take over PV and Call Center Medical Information intake, data capture, and responsibilities • Through global reach and local presence triage as well as PV case processing, literature PharmaLex covers medical information and PV • Need of additional support for NDA maintenance review, signal detection, aggregate report support on a multinational scale support, promotional materials development and systems review, and product complaint management • Extensive PharmaLex service portfolio allows • Prioritization of tasks, teamwork and company to outsource various activities (including transparency with client allowed PharmaLex to PV, Regulatory and Quality Management and tailor set up to company’s established Compliance) to one preferred provider processes and procedures