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.

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/.

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).

Billev Pharma – Simple Solutions in a Complex Environment