MediSanus Pharmaceutical Regulatory Affairs and Consultation Services for Drug Registration

MediSanus provides consultation services and management of marketing authorisations (MA), price applications, reimbursements, pharmacovigilance (PV), marketing and tenders for the drug development industry.

The company utilises more than 15 years’ experience to advise clients on the registration of products such as medical devices, medicines, dietary supplements, herbal medicines, veterinary drugs and cosmetics to regulatory authorities.

MediSanus understands the stringent regulatory standards of the EU and Slovenian pharmaceutical markets.

Management of regulatory affairs for pharmaceuticals

MediSanus offers regulatory affairs services for medicines, medical devices and food supplements. It has extensive knowledge of EU pharmaceutical regulation and helps companies to meet requirements quickly and efficiently.

The company also customises its consultation services to meet the needs of the client, using efficient planning and problem solving to avoid delays during the authorisation process.

Human and animal medicine registration submissions

MediSanus’ regulatory affairs professionals prepare submissions for innovative and generic medicines, including over-the-counter (OTC) products, vaccines, radiopharmaceuticals, blood products and veterinary pharmaceuticals.

The firm manages submissions through national, mutual recognition, decentralised and centralised procedures.

Registration of medical devices to CE and national drug databases

MediSanus offers advice on the legislation affecting medical device MA submissions and assists with the submission of clinical trials to the necessary authorities and ethics committees.

The company also assumes the role of authorised representative and helps with regulatory activities regarding importing and exporting.

MediSanus also advises on how to obtain Conformité Européene (CE) marking, works with qualified laboratories to conduct tests on devices and submits notifications for medical devices into the databases of countries in the European Economic Area (EEA) agreement zone.

Post-approval phase and market access

MediSanus manages regulatory support and submissions for the post-approval drug development phase, offering support and guidance for price and reimbursement. It also provides adaptation and translation of product information for summary of product characteristics (SMPC), labelling and public information leaflets (PIL).

The company also addresses pricing and market access issues, in the preparation, submission and management of various applications, renewals, and documentation updates.

The company also manages marketing materials reviews, harmonisation with approved medicinal products documents and communication with authorities, as well as with the preparation of packaging materials and proofreading.

Pharmacovigilance management solutions

MediSanus offers services for the appointment of a qualified person for pharmacovigilance (QPPV) and deputy officers.

The firm also conducts literature screenings, translation services and pharmacovigilance training.

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Medisanus do .o

Trzaska cesta 134

1 000 Ljubljana

Slovenia

+ 386 1 32 00 809 + 386 1 42 33 494 www.medisanus.com

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Medisanus do .o

Trzaska cesta 134

1 000 Ljubljana

Slovenia

+ 386 1 32 00 809 + 386 1 42 33 494 www.medisanus.com

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