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Regulatory - Regulatory affairs play an extremely important part in the pharmaceutical industry. We are well equipped to handle this.

Regulatory.

Regulatory affairs play an extremely important part in the pharmaceutical industry. We are well equipped to handle this.

For a regulatory affairs translation, linguistic competence in the source and target language and subject knowledge are not enough. The professionals involved also need excellent knowledge of the regulatory framework, documents and procedures.

We specialise in all medical and pharmaceutical regulatory affairs translation, including:

  • all EU product information documentation, both centralised and decentralised (mutual recognition, MR), such as:
    • Summaries of product characteristics (SmPCs)
    • Labelling
    • Patient information leaflets (PILs)
    • All Annexes
  • Marketing authorisation applications (MAAs)
  • All veterinary documentation
  • All medicines agencies documentation

In addition to our usual meticulous quality control, for regulatory affairs translation we always make sure we use official approved templates and terminology, including:

  • EMA quality review of documents (QRD) templates, current and/or past versions, according to your needs
    • centralised procedure (current version: 10, 04/2016)
    • decentralised/mutual recognition procedure (current version: 4, 02/2016)
  • all relevant appendices:
    • Appendix I – Statements for use in section 4.6 “Pregnancy and lactation” of the SmPC
    • Appendix II – Medical Dictionary for Regulatory Activities (MedDRA) terminology to be used in section 4.8 “Undesirable effects” of the SmPC
    • Appendix III – Storage conditions statements to be used in the SmPC, labelling and PIL
    • Appendix IV – Terms and abbreviations for “batch number” and “expiry date”
    • Appendix V – Adverse drug reaction reporting details
  • Medical Dictionary for Regulatory Activities (MedDRA, current version: 19.1)
  • European Directorate for the Quality of Medicines & HealthCare (EDQM) Standard terms
  • any relevant country‑specific official medicines agency documentation

Go to our Client Testimonials page to see how we help.

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