Variations – Support Services

We support regulatory departments by coordinating all the necessary language services that relate to notifications of changes/variations. We will take over the maintenance of your product information and deal with the incorporation of all changes in all the languages involved. In addition, we will support you in the preparation of documents for submission. At your request, we will deal with communications with the regulatory authorities with respect to all language-related queries concerning the submitted texts. For this purpose, we are able to call on a worldwide network of specialist medical translators. Our teams will support you in all questions concerning your product information and the applicable regulations.

Services (examples)

  • Technical translations for SmPC/PL and label documents
  • Core Safety Profile – Incorporation of new adverse events/effects and warnings into existing texts and all translations
  • New study results – Incorporation of new study results into SmPC and PL
  • Consistency checks – Checking the consistency of existing translations with reference texts.
  • QRD compliance – Checking QRD template use
  • Formatting – Checking and adjustment of text formatting in accordance with QRD requirements
  • Annex structure – Creation of combined texts or separation of strengths and pharmaceutical forms
  • Core Data Sheets – Adjustment to the contents of Core Data Sheets
  • Changes of names and addresses
  • Numerical control - checking of all numbers in the document
  • Editing

Process Support

  • Linguistic Review – Support during the whole linguistic review
  • Present/proposed tables – Creation of a detailed list of all changes
  • QRD 2 Form – Documentation of regulatory interaction
  • Annex A – Translation of regulatory changes
  • PDF - Creation of PDF files with bookmarks in accordance with EMA requirements
  • Coordination of queries – Responses to questions from regulatory assessors concerning the translations and checking by specialist translators of changes made by regulatory authorities
  • Time management with respect to compliance with all deadlines

If you have any questions about our services with respect to variations, you can discuss this with our experts at any time. We look forward to your call.