Mette Skaarup Pedersen

Mette Skaarup Pedersen
Cand.Scient.Pharm., Senior Regulatory Affairs Manager

Mette Skaarup Pedersen is M.Sc. in Pharmaceutical sciences and has been with Billev Pharma since September 2008 as a Regulatory Affairs Manager. As of October 2023 Mette will hold the position as Senior Regulatory Affairs Manager. 

  •  Has more than 10 years of experience within Regulatory Affairs and works mainly with DCP, MRP and national procedures.
  • Wide experience with translation and proofreading of product information (SmPC, PL and labelling) and proofreading of mock-ups

Works both with human and veterinary medicinal products.

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.

Latest News

Simple solutions in a complex PV environment

We are happily handling an increasing number of pharmacovigilance responsibilities for our clients in a complex pharmacovigilance environment. Our team of pharmacovigilance experts is now organised in three different fields – Human Accounts, Veterinary Accounts, and...

Dyrlæger i life science

I det nyeste nummer af Pharma kan du læse om vores kollega Charlotte Lindorf Eriksen og hendes arbejde med pharmacovigilance som dyrlæge i Billev Pharma Pharma nr. 3 2023—Side 14 (ipaper.io). Charlotte er netop blevet forfremmet til Head of Pharmacovigilance og har...