Can Your eCTD Publishing Solution Take You to the Next Level?

Ours Can.
Are you planning to file an original eCTD application? Or is your organization dealing with a heavy volume of application maintenance submissions and need extra publishing support? Why not work with a company that has more eCTD experience than any other, values its customers, and is dedicated to offering the personal touch lost in today’s market?

At GlobalSubmit there is no submission project too big or too small. We have the experience, manpower, and resources to provide full-service eCTD submission outsourcing or to augment your existing staff by providing publishing support to get you through peak or undermanned times. Our collaborative approach provides you with personalized attention and sensitivity to your unique business needs, not to mention being FDA’s exclusive eCTD review and validation software provider. 

We are more than an eCTD quality assurance platform. We are the turn-key solution to address your needs ranging from eCTD compilation, ESG transmission, publishing, quality checking, eCTD readiness, best practice implementation, and more. You name it, we do it.

Let GlobalSubmit help you take your submissions to the next level. 

Our team of experts are highly qualified to assist you in your electronic publishing efforts, such as:

  • Scan/Input Capture Services
  • Standardization of Documents to Support eCTD Format
  • Document prep, formatting, publishing, eCTD buliding, and submitting    
  • Document Amendments, Revision & Resubmission
  • Assembly & Quality Checking of eCTD Documents
  • Provide eCTD outsourcing for clinical trial and marketing applications (i.e., IND, NDA, BLA, MAA, NDS, etc.) 
  • Provide complete outsourcing or staff augmentation for eCTD publishing and submissions

Additional benefits include:

  • See real-time progress of your submission with GlobalSubmit Cloud
  • Get customized client-focused services
  • Leverage our key relationships with regulators to ensure submission success
  • Ensure superior communication and attention with US offices on the East and West coasts    

     

Find out what our publishing services can do for you. Contact us at 888-840-9580.