Regulatory Publishing & IDMP

Regulatory Publishing & IDMP

Publishing

You can rely on our experienced team and efficient use of electronic tools to prepare all or part of your paper or electronic submissions (eCTD & NeeS), to ensure that all electronic files meet the technical requirements of the health authorities. The services we offer include:

  • Formatting and electronic linking of documents
  • Assembly and publishing in eCTD & NeeS formats
  • Submission of all types of regulatory files/dossiers (new registration, variation, renewal, etc.)
  • Submission of regulatory applications through CESP or e-submission gateway.

IDMP

Identification of Medicinal Products (IDMP) is expected to improve patients´ safety worldwide. The implementation of IDMP within companies is a huge undertaking for which many companies encounter difficulties. Our consultants can provide you with a detailed plan on the requirements to implement IDMP in your company within the given timelines.

Discover our last white Paper

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