Our drug safety services

We provide a complete package of drug safety services which are specifically tailored to meet your needs.

Our drug safety services include the full management of adverse events originating from pre- and post-authorization studies and spontaneous reports, access to a validated drug safety database, expedited reporting in accordance with the national and international requirements, medical information services, writing services of all safety-related documents, and support in creation and management of your standard operating procedures.

We also prepare periodic safety update reports, annual safety reports, risk management plans, responses to regulatory authorities' queries, and any other safety related documents.

Our drug safety team operates in compliance with all regulations and international standards, including ICH, FDA and EMEA.

For more detailed information, please see below.