Our regulatory services are regularly used by small, medium and large European pharmaceutical companies.
With experience in different therapeutic areas (SZS, ophthalmology, oncology, pain, infectious diseases, gynecology, gastroenterology, cardiology) and with different pharmaceutical forms (oral, parenteral and topical formulations), we have so far registered numerous innovative and generic drugs, vaccines, herbal medicines , radiopharmaceuticals, blood derivatives and blood plasma products, and medical gases.
- approval for conducting a clinical trial
- authorization for putting the finished medicine on the market
- application for placing a medical product on the market
- MZ approval for food supplements
- registration of cosmetic products on CPNP
- marketing of items of general use
Clinical trials
Professional evaluation of the submitted documentation; preparation and/or revision of informed consent according to EU/national requirements; preparation of documentation for respondents; preparation, revision and elimination of deficiencies in the investigational drug file (IMPD); submission of requests to ethical commissions and regulatory authorities; communication with ethics commissions and regulatory bodies; submission of amendments and additions to the study documentation, up to the final report
Drug registrations
creation of registration documentation (Module I-Module V); preparation of expert reports for non-clinical and clinical documentation; creation of information about the drug in QRD format in English and translations into local languages (SI/HR/CS/BiH/MN/MK); submission of requests to regulatory authorities in the format chosen by the client (NTA/CTD/NeeS/eCTD); communication with regulatory bodies; submission of amendments during the life cycle of the drug; creation, revision and printing of marketing materials in accordance with the approved information about the drug