Regulatory Services

Day Zero provides the following regulatory services:

Dossier Compilation

  • Compiling of m1-m5
  • Audit of the quality part of the dossier
  • Dossier conversion to eCTD

Through our extensive network of experts, Day Zero can also assist with the clinical/ non-clinical parts of the dossier.

MA application

We can assist in creating a registration strategy and in overseeing all EU and UK regulatory submissions, timelines and communication with the authorities.

  • National Submissions
  • Mutual Recognition Procedures
  • Decentralised Procedures
  • Central Procedures
  • Duplicate Procedures
  • CMDh referrals
  • CHMP referrals
  • 0 day Repeat Use MRP’s
  • Act as marketing authorisation holder (MAH)
  • Parallel import applications for Iceland

Herbal Medicinal products

Day Zero has experience with the submission of herbal products through traditional and well-established use procedures.

Post regulatory procedure

Following the conclusion of a procedure, Day Zero can provide Icelandic translation of the product information and through the Eudracon network we can provide translations, proof reading and submission of the national phase within the EU and Switzerland.

Other post-procedure services include:

  • Follow up of national phases, translation of MA’s
  • Creation and translation of educational materials
  • Review/approval of Icelandic packaging materials for submission and printing
  • Coordination of pan-Nordic labelling projects
  • Assistance obtaining VNR numbers for Nordic countries

Life Cycle Management

  • Variations
  • Renewals
  • MAH transfers
  • Withdrawals
  • RMS transfers
  • Sunset Clause

Outside EU

  • CPP applications
  • GCC regional eCTD applications

For further information on our available regulatory services, please contact