Safety & Pharmacovigilance

Monitoring the safety of medicines is a continuous process, starting from the earliest clinical studies and extending throughout the post-marketing period. Due to the growing importance of pharmacovigilance, we have established reputable pharmacovigilance groups. We help pharmaceutical companies to process product safety data to ensure compliance with regulations and to establish quality safety databases for effective safety monitoring.

Area of expertise 

  • Reception, instruction, coding and reporting of side effects cases to the parent company and the health authorities
  • Entering cases in databases
  • Writing of CIOMS forms
  • Signal detection
  • Implementation and submission of the PSUR schedule to the health authorities
  • Writing PSURs and DSURs related to the parent company