Billev Pharma has for several years assisted companies with applications for registration of medicinal products for human use.
Regardless of the procedure type: National, Mutual Recognition (MRP), Decentralised (DCP), electronic (eCTD, NeeS) or by paper we have years of experience to be utilized.
As will be well known most companies have great backlogs when it comes to maintenance and compliance of registered products and their files.
We assist several of our clients with total overhaul of these matters enabling companies to concentrate on other aspects of regulatory affairs. At the same time, we help with strategic planning of the full product portfolio maintenance for these companies.