Preparing to Submit Your eCTD?

Take a Look at This First

If one of these companies sounds like you, you may want to talk to us about eCTD Readiness.

Company A: A medium-sized pharma ready to move from paper to outsourced eCTD, but doesn’t understand impact or best practices.

Company B: A small biotech about to produce a new IND. It needs to choose a publishing partner and understand what it needs to do to interact efficiently with that partner.

Company C: A pharma that's been using a publishing partner for several years and needs to decide whether to bring publishing in-house. If publishing moves in, the company needs to understand the impact on its people, processes and technology.

Company D has decided to bring publishing in-house, and needs to choose a tool, develop processes and train staff.

Although these companies are at different stages and making different decisions, there is a common thread:

  • They need education on requirements and best practices to make sound decisions and develop comprehensive and realistic plans.
  • Their in-house resources are unlikely to have the time and experience needed to proceed in an efficient manner
  • They are all facing risk – and anticipating benefit.

GlobalSubmit's targeted eCTD Readiness services can help you to overcome challenges, mitigate risk, reduce cost, maximize company benefits, and achieve realistic and meaningful eSubmission goals. Our approach is flexible and collaborative:

  • We have more eCTD experience than any other vendor, and know what it takes to ensure submission success. Working directly with the FDA, we assisted them with their readiness for the new Module 1 Specification.  
  • We conduct submission-specific gap analyses to ensure a plan is in place for your IND, NDA, BLA, MAA, NDS, etc. prior to the impending eCTD mandate.
  • We work with you beforehand, we strive to understand your current state and goals
  • We present an educational and planning workshop with materials tailored towards your education and planning needs, respecting your goals and constraints.  
  • We work with you to decide what deliverables you want to produce, and what deliverables you want GlobalSubmit to produce.
  • We provide the resources you need; whether it is educational materials, SOPs best practices, templates, project plan, RFI/RFP for publishing software or services, eCTD handbook, etc.
  • Regardless of who produces the deliverables, our accelerators (template plans, checklists, handbooks, RFIs, etc.) will allow high quality materials to be created in a cost-effective manner.  

Find out what our Regulatory Operations Services can do for you. Contact us at 888-840-9580.