Submissions Publishing

Submission Publishing Services

We as your comprehensive submissions publishing partner have Global Regulatory submissions expertise in NDA, BLA, MAA, ANDA, IND, NDS, DMF, CTA, supplements, amendments, variations and SPL to name a few.

We do

  • Submissions Project Plan, submission map creation.
  • Submission compilation & Lifecycle Management.
  • Submission document development/ document publishing.
  • Response to agency queries, translations & linguistic reviews.
  • Agency Specific document formatting and Publishing.
  • Develop CTD structuring and document content plan
  • eSubmissions Gateway setup
  • Paper to Electronic document conversion
  • Enable DMF submission in eCTD format by providing, document mapping, lifecycle management including amendments and annual reports & electronic signatures.