Clinres Nova Ltd.Your CRO in SouthEast Europe

Clinres-nova is a contract research and consulting organization that provides clinical and regulatory expertise to the pharmaceutical and biotechnology industries

Service 01

Clinical Research
Study Management

We have expertise in bringing medical infromation, media and patients together to understand the advantages of your product.

Service 02

Regulatory Services
Expertise & Experience

Co-ordination with authorities, client representation, MAH services, Pharmacovigilance, Translation services.

Service 03

Statistics and Medical Writing
From Sample to Report

From estimation of sample size, randomisation schedule and statistical plan to full analysis and ICH compliant reports.

Service 04

Data management
Paper and Electronic

With almost 20 years of experience in all aspects of data management, we offer full range of services in paper and electronic data management.


Updates and Links

Dossier upgrade

Relevant information regarding dossier upgrade and readability testing at Croatian Agency's for Medicinal Products and Medical Devices pages.

Appendix to Annex V ... the Act concerning the conditions of accession of the Republic of Croatia.


As of 21 July 2012, new requirements for marketing authorisation applications are introduced in Directive 2001/83/EC.


Atemplates for product information for use by applicants and marketing-authorisation holders. The European Medicines Agency's Working Group on Quality Review of Documents (QRD) develops, reviews and updates these templates.

Readability Testing

Image 01

One of the key services in documentation (dossier) upgrade in process of joining the EU.

We were among the first in Croatia to offer extensive readability testing to our customers. Over the years, we assembled an experienced and well trained team, flexible in solving readability issues in light of the approaching deadlines.


Our Experience

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Our customers include pharmaceutical, biotech, device companies and contract research.

Some of our partners are Acraf S.p.A., Alkaloid a.d., Amway Corp., AstraZeneca, Boehringer Ingelheim, Bosnalijek d.d., CSC Pharmaceuticals Handels GmbH., Cyathus Exquirere Pharmaforschungs GmbH, Eli Lilly....