Our Services - Regulatory Operations
We provide Regulatory Operations and Publishing services for worldwide submissions in eCTD, Nees, and PDF format.
- Complete application forms
- Author cover letter, tracking table (EU), review guide (US), life cycle management table (CA) etc.
- Prepare template CTD documents and advise how to use templates in-
- Arrange legalization by embassy or apostille for documents
- Advise on fee payment process to Health Authorities
- Submit dossiers to Health Authorities
- Maintain registration databases
- Convert any MS word document to eCTD compliant PDF document
- Advise on how to author eCTD compliant documents in-house
- Publish dossiers in eCTD, NeeS and PDF format
- Convert dossier to eCTD or NeeS format