eCTD has been the only accepted format in the centralised procedure for some years now.
As from July 2015 eCTD is mandatory for new marketing authorisation for human medicinal product under the DCP.
The eCTD format is becoming mandatory in all European procedure and for most regulatory activities, new marketing authorisations as well as variations eCTD is the preferred format eventually eliminating the NeeS format.
The actual situation changes from month to month. Therefore, there is an uncertainty among applicants as to what means to use and when to start. We follow this development closely and are always fully updated.
With our inside knowledge we will be able to advise our clients on the most appropriate method and timeline for submission.
We have invested in the necessary software in order to be able to compile and submit electronically.
We can assist with full format conversion from paper or NeeS to eCTD as well as maintenance of your electronic file. We can also provide parts of the files in electronic format where that is feasible for you.
As of July 2016 the VNeeS format will be mandatory for new marketing authorisations in CP and DCP. VNeeS is the electronic format for veterinary medicinal products. In this field, where eCTD is not used, the electronic submissions are already possible in most countries.
Please contact us to hear more about the future systems for submission of applications and for maintenance of the regulatory work.
We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.
We offer high quality medical & pharmaceutical translations into and from several European languages.
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.
At Billev Pharma we have a team of qualified lead auditors within GVP, VGVP, GMP and GDP. Last year our audit team conducted more than 10 remote pharmacovigilance audits and 10 onsite GDP audits of warehouses. We conduct remote and onsite audits within the EU as well...
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...
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...