Det er blevet en tradition og vores team bliver større.
We value our old and new clients
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.
Denmark bids to host EMA headquarters in Copenhagen
Yesterdy, the Danish Government officially announced its candidacy for hosting the European Medicines Agency (EMA) in Denmark.
Pharmacovigilance and Regulatory Conferences
We are attending the annual Medicines for Europe Pharmacovigilance and Regulatory Conferences next week January 25-27 in London. Meet us there…
Merry Christmas and Happy New Year!
The Billev Pharma Team wish our clients and business partners a Merry Christmas and Happy New Year!
We are looking forward to continue our good cooperation in 2017.
We will be closed over Christmas and New Year. If you have any urgent issues, please contact the management in this period.
Veterinary NeeS mandatory as of 1 January 2017
Did you know that the Veterinary NeeS (VNeeS) format will become mandatory for ALL submissions in CP, DCP and MRP next year? And that the Danish Medicines Agency just published the news that VNeeS is the only acceptable electronic format in all cases as of 1 January 2017?
Do you think that Denmark is the only country that will follow the European eSubmission Roadmap? Billev Pharma has the knowledge to guide you and the software to compile your electronic submissions. Read more about our service here: http://www.billevpharma.dk/services/electronic-submission/.
Tæl skridt
Vi deltager i Tæl skridt kampagnen fra den 19. september. Gå 10.000 skridt om dagen.
Generational handover completed
In July Anja van Arkens and Ulrikke Lynge Jensen have assumed full ownership of Billev Pharma. Over the last year the company has grown to more than 15 employees.
Alt for damernes Kvindeløb 2016
Igen i år deltog et team fra Billev Pharma i Alt for damernes Kvindeløb.
A new Look for a Growing Organisation
We are launching our new website presenting our specialized and dedicated staff and our services within Regulatory Affairs and Pharmacovigilance.
The Billev Pharma team has expanded within the last year. Today, we are 14 around the table. Last week we were 13. Although some say that 13 is an unlucky number, we experience increasing demands for our services, especially within Pharmacovigilance, translations of product information, compilation and submission of MRPs and DCPs for human and veterinary products and compilation of electronic submissions (eCTD, NeeS and VNeeS).