Billev Pharma ApS

Medical and Regulatory Affairs Consultancy

News

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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

2011 Generational handover in Billev Pharma

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One of Europe’s oldest and most experienced pharmaceutical consulting companies has strengthened and rejuvenated its management. Two of our highly qualified pharmacists, the 45 years old Anja van Arkens and the 36 years old Ulrikke Lynge Jensen, became partners in Billev Pharma ApS on 1 May 2011.

They have both been working in the company since 2008. Because of their strong background with several years of experience in the pharmaceutical line of business they have exhibited great strength, flexibility and positive results in their work with the company’s clients. Therefore, it was natural to take one step further and convert the company to a partnership for the future.

Peter de Mayo Billev, Anja van Arkens and Ulrikke Lynge Jensen are happy to present the new concept. Together we will hold the company’s core values and create new growth and direction for the benefit of the company’s clients and business partners.