We now cover all areas within regulatory affairs

In February 2019 Susanne Thiilborg, Ph.D.Pharm., began a position as Regulatory Affairs Manager with Billev Pharma. Susanne has more than 20 years’ experience within analytical chemistry from the pharmaceutical company Lundbeck.

Susanne accounts for all possibilities and reviews the relevant issue from all aspects before drawing a conclusion.

With her extensive experience Susanne can help you with writing and reviewing the regulatory documentation for clinical trials (IMPD, IND), initial MAA/NDAs or maintenance activities such as variation applications. Also, she is able to assist you with compliance projects identifying and cleaning up GAPs in your quality documentation.

We are happy that Susanne has joined our company. With Susanne on our regulatory team we now cover all areas within regulatory affairs.

You can read more about Susanne’s qualifications on our website http://billevpharma.dk/about-2/staff/

Anniversaries in 2018

In 2018 we celebrated Billev Pharma’s 40 years anniversary and also 3 times 10th anniversaries.

Mette Skaarup Pedersen has been with us since 2008. Mette’s key area is proofreading and translation. Mette is highly respected among our clients for her eye for details – she is always willing to give a helping hand and a friendly smile.

We have also been with Billev Pharma for 10 years. We are proud to witness the expansion of the Billev Pharma team while aiming at providing our clients with useful and reliable support within the fields of regulatory affairs, pharmacovigilance and quality.

Anja and Ulrikke, Directors and Owners of Billev Pharma ApS

We started 2019 by welcoming 3 new employees in our Billev Pharma team

Trine Lorentzen, M.Sc. Pharm., filled the recently established post as QA Manager. Trine has several years of solid experience with Good Distribution Practice (GDP) and the function as Responsible Person.

Are you facing an inspection? Are you struggling to keep your QMS up to date? Are you lacking the capacity or qualifications to audit you contract takers or suppliers? Would you like to have an external expert opinion during your self-inspection or audit?

Trine can determine the GAPs in your QMS and help you close them. 

Trine has hosted many inspections with impressive results. She is an experienced GDP Lead auditor and conducts her host function in a pleasant and constructive tone with a flash of humour.

You can read more about Trine’s qualifications on our website http://billevpharma.dk/about-2/staff/

Could you use a helping hand in your regulatory department, or do you lack the specialised staff in-house to handle European procedures?

In June 2018 Karen Jensen, M.Sc. Pharm., joined our regulatory team. Karen and our regulatory team can assist you with both European and national initial MAAs or maintenance activities.

Karen is a generous co-worker and has more than 16 years of experience working as Special Adviser with the Danish Medicines Agency. She has a flair for quickly identifying the heart of the matter and for problem solving. Karen has excellent communication skills, also when it comes to extremely specialized topics, and it goes without saying that she strives to meet the deadline. Karen joining our team has indeed strengthened our knowledge within regulatory affairs. You can read more about Karen’s qualifications here http://billevpharma.dk/employees/karen-jensen/

Billev Pharma experiences increasing demand for our Pharmacovigilance services and our team working with Pharmacovigilance is growing

Lisbeth Bonde Jensen, M.Sc. Pharmacy and Pg. Diploma in Pharmacovigilance, has been with us since April 2016. Lisbeth has more than 10 years of experience with Pharmacovigilance from the pharmaceutical industry.

Are you interested in working with our highly skilled and specialised Pharmacovigilance team? Then contact us at hello@billevpharma.dk