Publishing

We know how important submission deadlines are and publishing is the last stage before submission. We are committed to providing a high quality, on-time service. We validate the publishing output through a variety of electronic validators to ensure that this is accepted by the Agencies. We can publish any type of applications for you in e-CTD or NeeS format:

  • MAA
  • variations
  • renewals
  • CSRs
  • briefing packages

Interested in our service? Let's talk

“Fred-CMC are experts in pharmaceutical quality changes, writing variations, whilst contracting out publishing for European submissions. I like to work with Eudrac as I can trust the quality they provide will keep my own clients happy. They work to my client's requirements, respect pre-agreed time lines and are up-to-date with regulatory requirements and practices. They go beyond just publishing by being real partners in the preparation of dossiers.”

F. David, Owner of Fred-CMC