Regulatory Services

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Clinres-Nova is a Contract Research Organisation (CRO) located in Zagreb, Croatia. Over the period of last 20 years we have formed a highly educated team of medical and pharmaceutical professionals. We provide clinical and regulatory expertise to the pharmaceutical and biotechnology industries.

Our team provides regulatory services required by European as well as Croatian health and drug legislatives. We also cover all services required by the EU Accession Treaty so our clients can remain direct or indirect (through Clinres Nova) Marketing Authorisation Holders on the Croatian and European medical products market.
Clinres Nova provides regulatory services for drugs, homeopatic products, medical products and medical devices, food additives and cosmetic preparations for Croatian and foreign clients.

Our services

Following you will find the list of our services and solutions we are able to provide. Covering all aspects of regulatory services, from consulting before the beginning of the registration process, through registration representation, pharmacovigilance and other post-registration activities, we can provide you a professional and competent approach for all your regulatory needs.

Pre-registration consulting

Authorised representation of Marketing Authorisation Holders in communication and regulatory services with the regulatory authorities and agencies.

Registration of drugs and homeopatic products according to national nCadreac and MRP/DCP procedures.

Registration of medicinal products
Registration of medicinal products (addition to register), food supplements and cosmetic preparations.

Post-registration procedures for approved drugs and homeopatic devices: renewals and changes.

Range of services in area of pharmacovigilance of drugs and medicinal products through QPPV (EU Qualified Person for Pharmacovigilance). Services include creation of all necessary documentation for Marketing Authorisartion Holders with DDPS (Detailed Description of Pharmacovigilance System), RMP (Risk Management Plan) as well as preparation of PSURs (Periodic Safety Update Reports). We also cover all local pharmacovigilance procedures, as defined by the regulatory authorities in Croatia.

Readability testing for PIL (Patient Information Leaflet) and other documentation, including documents in Braille alphabet. All testing and reporting is done according to the valid EU regulatory guidelines.

Non-clinical and clinical medicinal products documentation preparation - reports and summaries.

Inner- and outer-packaging mock-ups production.

Professional translation services: translations of documents from the fields of medicine and pharmacology, correction of translations, certified translations, technical documents translation, SPC, PIL and packaging translations.

Formatting according to QRD guidelines (PALC III).

Re-formatting and upgrades of medicinal products documentation (STD) to EU CTD format.