Regulatory – Medica Linea Pharm
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Medica Linea supports partner companies in all pharmaceutical and medical devices licensing, trade, and promotional requirements in Serbia & the region.

Entering a new market, with its own rules and regulations, can be a hard task for any manufacturer. We want to make it a lot easier for you.

We prepare all the necessary types of submissions for both human medicinal products and medical devices. In doing so, we help our partners develop a regulatory strategy for new and existing products. Based on the needs of our partners, we compile, publish and validate dossiers in the eCTD and NeeS/VNeeS format. Medica Linea is fully capable of taking on all of the required Regulatory Affairs work on behalf of our partnering companies. Or just provide a helping hand as and when it is needed.

Medica Linea Pharm holds a significant number of MAs in our name, and we fully understand the compliance and regulatory requirements needed for our partners as a named license holder.