We value our old and new clients

Aug 16, 2017

And have assisted some of our old clients with regulatory affairs and pharmacovigilance since Billev Pharma was founded in 1978 – some on a daily basis and others when they need our help.

With the growth of the company we continue to build relationships with new clients. We offer a wide range of services and in first half year of 2017, we have worked on assignments, such as:

·       Upgrading of quality management system to GMP standard

·       Assuming temporary responsible person/quality responsible for two companies holding GDP authorisation

·       Translating product information for both generics and brand leaders

·       Writing the quality part for a veterinary medicinal product to be submitted in the centralised procedure

·       Writing and/or compiling 3 human DCPs.

Tags:
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.