Regulatory Affairs

Regulatory Affairs

European Medicines Agency (EMA) Marketing Authorisation Applications (MAAs) and Variations using QRD (Quality Review Documents) Word templates for both human and veterinary medicinal products.

DWL has extensive experience in the translation of Product Information required by the EMA as part of their procedures for MAAs and Variations.

Since the First Pharmaceutical Directive in 1965 introduced Europe to the Marketing Authorisation, DWL has translated product information for many of the world’s most important drugs.

Later, DWL supported the European pharmaceutical industry in tackling the linguistic and regulatory impact of the accession of new Member States, the advent of the Mutual Recognition Procedure and later the Decentralised Procedure.

Today DWL translate all necessary regulatory documentation relating to clinical, non-clinical and product information for the Common Technical Document (CTD) and all post-marketing authorisation variations, pharmacovigilance and pharmaco-economic documentation.

Through our association with The Organisation for Professionals in Regulatory Affairs (TOPRA), Clinical and Contract Research Association (CCRA) as well as regular attendance at regulatory events and seminars we stay ahead of an ever-changing regulatory landscape.

DWL can handle all aspects of your:

  • Centralised Procedure (CP)
  • Type IA/IB and Type II Variations
  • Mutual Recognition Procedure (MRP)
  • Decentralised Procedure (DCP)
  • Referral Procedure

DWL is involved in the translation process for MAAs on a daily basis and covers all relevant aspects of the different procedures such as:

  • First drafts
  • Rapporteur changes
  • CHMP opinion changes
  • Liaison with National
  • Competent Authorities to approve member state comments
  • Bookmarking of pdf conversions
  • Completion of QRD Form 2 and submission checklist

Non-EU Marketing Authorisation Applications involving the translation of parts of the Common Technical Document (CTD) or similar types of documentation.

With the increasing amount of regulation in traditional and emerging markets, DWL’s service involves the translation of:

  • Regulations into English from the target market language ]]
  • Documentation for submission into the target market language

We foster close relationships with Regulatory Affairs Specialists in Europe to ensure that we may provide solutions to our customers in an ever-changing regulatory landscape.

Contact us to discuss your submission and timelines.

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