Regulatory Operations

Are you ready for the FDA requirement for mandatory electronic submissions in 2017?  All paper based dossiers must be converted to electronic format!  PharmaLex is prepared to help you meet this deadline.

The paperless electronic submission of documents and communication to FDA documents has now become standard procedure.  Rely on our experienced regulatory operations team to compile well-structured, submission-ready electronic documentation. Your data can be prepared and transmitted directly to the FDA through their electronic gateway. Using the latest validated software, we compile your reports and communications into formal submissions that are compliant with all Agency requirements. Our team will also perform the individual report publishing and hyper-link activities within and between documents for ease of review of the submission by FDA staff.

For more than a decade we have been leaders in the efforts to harmonize electronic submission requirements throughout the world. These years of experience and close collaboration with experts from the pharmaceuticals industry, software developers and global regulatory Agencies have given us a deep insight into the field and a comprehensive store of knowledge that goes well beyond the norm for most companies providing these services.

Our regulatory operations services include:

  • Dossier planning and compilation (eCTD, IND, NDA, BLA, ANDA, etc.)
  • Document and Report electronic publishing
  • Project Management for large submissions
  • Sequence and Dossier Submission through FDA electronic gateway