Our Expertise

Excellence of Quality of Service

Pharmacovigilance

Clinical Operations

Regulatory Affairs

Medical Writing

Pharmacovigilance

In an increasingly stringent regulatory context, pharmacovigilance is, now more than ever, a major issue for our clients. We provide outsourcing solutions to help you realize your product monitoring programs:

  • Reception, instruction, coding and reporting of EI cases to the parent company and the health authorities
  • Entering of cases in databases
  • Writing of CIOMS cards
  • Signal Detection
  • Implementation and submission of the PSURs to the health authorities
  • Writing of PSURs and DSURs related to the parent company

Clinical Operations

Excelya assists you in implementing and managing Phase I to IV clinical studies. We provide outsourcing services for CTA, ARC and Project Manager positions:

  • International Project Management
  • Recruitment Strategies
  • Implementation and Monitoring of studies
  • Management of Investigating Centres

Regulatory Affairs

Excelya manages your regulatory projects and offers the assistance of Regulatory Affairs Officers.

  • Registration and Filing Strategies
  • Drafting of all or part of the AMM
  • Answering questions from the authorities
  • Publication
  • Control of promotional items

Medical Writing

We provide outsourcing services for the drafting of all your documents.

  • Definition and drafting of protocols
  • CR definition and writing
  • Definition and writing of integrated clinical and statistical reports
  • Inherent publications