European Medicines Agency (EMA) is a decentralized agency of the European Union, responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for the EU market.

What is the challenge?

The client came to us with a challenge: to eliminate non-compliance issues in human, veterinary pharmaceuticals’ documentation (annotations, inserts, questionnaires, protocols, etc.) submitted for authorization and ensure timely regulatory updates of product information across the EU. The required service mainly includes document translation, revision and final verification under the specific quality standards of EMA QRD (Quality Review of Documents) system on a regular basis.

 

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It has been the 11th consecutive year of our cooperation, needless to say, the client is happy with the result.

 

How do we solve it?

  • Built a dedicated and specialized team of an experienced project manager, 21 subject-matter translators, 16 revisers and 4 QA engineers to work with the projects on a regular basis.
  • The project manager issued specific project instructions and trained the team to work under the specific quality standards of EMA QRD (Quality Review of Documents) system.
  • Developed a specific project workflow to ensure timely multilingual project execution under tight deadlines.
  • Follow the Standard Terms Database, drawn up and approved by the European Pharmacopoeia Commission under the request of the EU Commission.

What are the results?

We help European Medicine Agency (EMA) eliminate non-compliance issues in human, veterinary pharmaceuticals’ documentation submitted for authorization and ensure timely regulatory updates of product information across the EU under their specific quality standards of QRD (Quality Review of Documents) system on a regular basis. It has been the 11th consecutive year of our cooperation, needless to say, the client is happy with the result.

Related Story

How We Helped  Minimize The Risk Of Product Documentation Non-Compliance Across Different Markets

Related Story

 

How We Helped  Minimize The Risk Of Product Documentation Non-Compliance Across Different Markets