You would like to focus on the regulatory contents of your submission?
You don't have the resources to care about the technical aspects?
Tired of cost and time-intensive system implementation and validation projects?
- We create and submit your eCTDs (or NeeS) for all registration procedures and product types worldwide. Regardless whether your product is running through a MRP/DCP or a Centralized Procedure, whether it will go through a full NDA or an ANDA - our team has more than 10 years experience from the life-science industry.
- We manage your complete eCTD lifecycle and advice you in all lifecycle - related questions
- We support Structured Product Labeling (SPL) and Study Tagging Files (STFs) for U.S. eCTDs
- We also take care of your submission documents. Whether we talk about MS Word or PDF documents or complex Study Reports. Our document formatting and publishing services ensures that your submission documents are of a high-quality and readily formatted to ease navigation and review.
Our team has a proven track record to meet even the most challenging submission deadlines. We are proud to say that in more than 2.000 succesful submissions of eCTD sequences, we never missed a single deadline.
If you should have already your own in-house infrastructure and eCTD publishing system in place, we are happy to support your team on-site or remote, e.g. in case of manpower shortages.