STARODUB

EXPERTS IN REGULATORY AFFAIRS

Strategic, Timely, Accurate, Regulatory Services To Every Client

Reliable

 

Efficient

 

Knowledgable


Our Services - Regulatory Operations


We provide Regulatory Operations and Publishing services for worldwide submissions in eCTD, Nees, and PDF format.

Regulatory operation


  • 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

Publishing services


  • 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


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