Regulatory Submissions

Everest can assist you in preparing and submitting your regulatory application.

We will prepare your regulatory application (e.g. IND, NDA, BLA) in eCTD-format, ensuring compliance with all regulatory agency technical requirements (e.g. CTD backbone structure, document type, required files) so that your submission will swiftly pass technical validation and arrive to the reviewers without delay.

  1. Regulatory Submissions Using eCTD.

  2. eCTD submissions can be sent directly to regulatory agencies (e.g. FDA, EMA, and Health Canada) on client’s behalf.

  3. Submissions can be sent electronically to FDA through their Electronic Submissions Gateway.

  4. In-house submission build with options for document publishing, CDISC dataset preparation, SPL build, standard letter or A4 paper submission printing for agencies or EU Member States.

  5. Dedicated server able to send and receive documents by secure VPN connecting to client.

  6. SOP-controlled process from start to finish. Sponsor audited; FDA remote audit of documentation with no findings/faults.

  7. Regulatory support for agency communications available through partnering regulatory firms.

Have questions?
Email Us
Subscribe now to receive updates
Subscribe To ECRS Corp