National registration

We have assisted with the National procedure from the very beginning of our history in 1978.

Now this procedure has been mostly replaced by European procedures. The National procedure is however still a relevant option if a marketing authorisation is desired in only one European member state.

The National procedure is also the starting point for the Mutual Recognition procedure (MRP). It should be pointed out that due to lack of resources at the different European health agencies a national application followed by MRP can be a slightly longer exercise than the Decentral procedure (DCP).

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.

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