eSubmissions Services

eSubmissions are now in mainstream use in both Europe and the USA.  eCTD is the mandatory electronic format for US NDA and EU centralised MAA submissions.  NeeS submissions are in widespread use for EU national, mutual recognition and decentralised procedures.  PIM is currently being implemented for submission of product information in the EU centralised procedure. 

Our regulatory submissions services include regulatory publishing and eCTD consultancy of all types. We have extensive experience with eCTD publishing, eCTD lifecycle management and NeeS submissions in Europe, as well as joint EU / US FDA applications.

Your eCTD submission will be managed by regulatory affairs professionals. As experienced eSubmission specialists, we know that our eCTD services and NeeS regulatory publishing is better managed by those who fully understand the regulatory process. Our successes in eCTD consultancy and providing high quality eCTD services - to deadline - suggests this is the best approach.

To add greater value to our eCTD submission services, we provide free eCTD templates. The templates promote consistency of formatting and compliance with the eCTD heading structure and granularity requirements, making the eCTD submission process more efficient.

PIM for EMA is also an area of growing interest for us. We’ve worked with two big pharma companies on legacy migration pilot projects and have developed robust practices and procedures that enable us to provide a high quality PIM service.

If you require any assistance with regulatory submissions from our eCTD publishing and eSubmission specialists, please contact us, at no obligation.