We are able to help pharma companies prepare for e-submissions (including non-eCTDs and eCTDs) by advising on:

• The adoption of processes for first-time-right authoring and publishing

• Implementation of a standardized document or content management system

• Implications of and best practice for document/dossier lifecycle management

• Dossier project management of MAAs and major variations

• Coordination with Regulatory Agencies on technical issues related to eCTD submissions
  

• Managing scanning and conversion to PDF

• eCTD readiness of documents, including paper and scanned images

• Assembly of electronic and paper dossiers

• Electronic hosting of regulatory dossiers on our dedicated server

• Burning CDs/DVDs and printing of labels

• Ensuring　that the dossiers can be printed anywhere in the world by preparation of print files for paper output

• Coordination of dispatch of CDs/DVDs and/or paper dossiers

• Ensuring the right level of granularity is applied. This optimizes re-use of documentation across multiple regions and impacts your submission maintenance.