We are dedicated to providing the same outstanding quality of service across all electronic submissions, be it a IND submission, a biologics license application (BLA), conversion to eCTD format or simply the maintenance of an existing application.
Our global presence and international network of publishing experts means we are perfectly placed to meet your needs in the US, Canada, Europe and elsewhere.
We provide continued support for all future sequences of your application.
We securely transmit to FDA or Health Canada using the authorized submission portal.
Our medical writers and MDs can author your regulatory documentation.
We provide regulatory project management and operations support as a matter of course.
If you are short-handed we can provide additional regulatory support at most levels. We supply ad-hoc staff members who are fully trained and ready to increase your deliverables. They can work with you ‘on-site’ or remotely.
We prepare documents for publishing by optimizing templates, hyperlinking, bookmarking, formatting and converting files to the necessary standards.
We provide SPL services, drug registration and listings, and 2253 submissions.
We deliver legacy paper submission publishing, NeeS and conversions to eCTD, including scanning services, record management, site closures and M&A document transfers.