Exclusive Services

We have a dedicated team who can support you in building your submission package in eCTD (or NeeS) and submitting these to the national competent authorities (NCA) either by CESP or through the national portals as appropriate for Europe and also to the FDA via the Electronic Submission Gateway (ESG).  

If you are moving from a paper based system to eCTD, we can take your raw dossier and format the file for electronic submission in a hassle free manner. 

eCTD publishing of all submissions or as an eCTD publishing back-up for any urgent sequences required, lifecycle management, validation for all published sequences, submission to the relevant health authorities.

Conversion of NeeS or paper dossiers to eCTD for Baseline submissions, We outline company strategy to implement a standard structure, format and granularity of eCTD dossiers submitted

We offer a complete and comprehensive pharmacovigilance service to assist you in meeting your legal obligations as Marketing Authorisation Holder (MAH). Our pharmacovigilance consultants have significant experience in working with companies all over the world.

Our Regulatory team is staffed by specialists with a wide variety of expertise.  Our Medical and Clinical services team assists companies in the management of clinical trials, medical writing and the provision of medical information services.