Regulatory Publishing & IDMP

BlueReg Group Drug Registration Regulatory Publishing & IDMP 2

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.

Registration Strategy

Preparation and writing for clinical study reports

CTD Dossier Writing

CMC Regulatory support