We support your products throughout the regulatory lifecycle with expert guidance. We assist with the preparation, submission, and maintenance of complete documentation before the competent authorities in the Republic of Serbia (ALIMS and the Ministry of Health).
Every product category follows its own procedure and authority in Serbia — here's how we handle each.
Preparation of dossiers in standardized eCTD / CTD format in accordance with the requirements of the Medicines and Medical Devices Agency of Serbia (ALIMS).
End-to-end management of procedures for granting marketing authorization for medicinal products, renewing authorization, and transferring authorization to another holder.
Preparation and submission of applications for all types of variations (IA, IB, II) in accordance with applicable regulations on amendments to marketing authorizations.
Preparation and harmonization of the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and packaging in Serbian, as well as support in establishing and maintaining a pharmacovigilance system.
Management of the complete registration procedure for all risk classes (Classes I, IIa, IIb, III, as well as in vitro diagnostic medical devices – IVD) in accordance with the Law on Medical Devices of the Republic of Serbia.
Preparation and review of the technical file, preparation of clinical evaluation, verification of compliance with Essential Requirements, and preparation of documentation for submission to a designated body or ALIMS.
Establishment of procedures for monitoring medical devices on the market, reporting incidents and adverse events (vigilance), and implementing post-market clinical follow-up plans (PMCF).
Organization of composition testing, preparation of expert opinions and categorization by authorized healthcare/pharmaceutical institutions in Serbia (e.g., Faculty of Pharmacy, Institute of Public Health).
Preparation of the complete application file and management of the procedure until the Decision on entry of the dietary product in the Ministry of Health database is obtained.
Timely submission of requests for renewal of database entry, as well as changes to labelling, composition, or manufacturer.
Review of product composition (INCI list) and preparation of label texts in accordance with the Law on Cosmetic Products and the accompanying rulebooks of the Republic of Serbia.
Preparation and organization of the Product Information File and the Cosmetic Product Safety Assessment before the product is placed on the market.
We provide comprehensive consulting services, guide you through complex regulatory procedures, and ensure that your products reach the market quickly, safely, and in full compliance with national and international regulations.
Our team consists of experts with many years of experience working with ALIMS, the Ministry of Health, and professional bodies in Serbia.
We reduce the risk of application rejection and shorten the time required for products to reach the market.
We provide support from the initial idea and compliance assessment, through certification and registration, to post-market surveillance.
Contact us for consultations and the preparation of an offer tailored to your business needs.