Services
Regulatory Affairs and Pharmacovigilance
We provide regulatory services with a team of highly qualified experts specialised in the field of regulation of human and veterinary medicinal products. In the field of registration of medicinal products, we perform all activities necessary for the placement of the medicinal products on the market as well as activities necessary for the maintenance of marketing authorisations:
- National Procedures (NP), Mutual Recognition Procedures (MRP) and Decentralised Procedures (DCP) – new application, extension, renewal, variations of marketing authorisation and notification.
- Centralised Procedures (CP):
- preparation and review of translations of the product information (SmPC, PIL, labelling) in accordance with the QRD and national requirements;
- advice on local specificities;
- preparation of blue-box applications.
- artwork review (proofreadings),
- review of marketing material,
- preparing applications for an exemption to the obligation of labelling a medicinal product in the Slovene language, for individual deviation from the terms of marketing authorisation and for the sunset clause,
- consultancy.
In addition, we also offer regulatory services for medical devices and food supplements, such as contact with the competent authority and translation and peer review/correction of texts.
Pharmacovigilance and vigilance of medical devices
Pharmacovigilance services include:
- a local pharmacovigilance contact with 24-hour availability,
- collecting and reporting suspected adverse events and other safety information,
- maintaining the pharmacovigilance system,
- preparing and maintaining standard operating procedures (SOPs),
- communication with the competent authority and our partners,
- reviewing nationally prescribed literature,
- monitoring of local legislation and HA website,
- preparation of applications for review of educational material (under the RMP) and preparation of DHPCs.
As part of our medical device vigilance services, we provide:
- local contact with 24-hour standby,
- communication with the competent authority (reporting to the competent authority about incidents with medical devices)
- informing customers in case of field safety notices and incidents with medical devices.
Reporting of suspected adverse events