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.
Services
Registration
We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
Pharmacovigilance
We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.
Translations
We offer high quality medical & pharmaceutical translations into and from several European languages.
Electronic submission
We are equipped to assist with any type of electronic submission and maintenance of your electronic file.
Special medicines areas
Herbal medicinal products, strong vitamin and mineral products, medicinal gasses, euphoriant substances, etc.
GDP & GMP Services
We offer full time and part time responsible person (RP) function and qualified person (QP) function.
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