Medical writing of regulatory documentation:
Medical writing in Pharmacovigilance:
Biosimilar medicines
We offer guidance on comparability testing and preparation of non-clinical and clinical documentation, as required per Article 10(4) of Directive 2001/83/EC for the licensing of biosimilar medicinal products. Our experts can assist you in the registration phase, as well as in the post-marketing phase by managing the product’s pharmacovigilance.
Operation title: BILLEV FARMACIJA VZHOD digitalizacija
Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund”. – Read more
Operation title: BILLEV FARMACIJA VZHOD digitalizacija Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund.” – Read more