A Czech Republic based fast-growing healthcare company specialized in Medical Devices (Class I & II a, & II b) and Health Products was aiming at registration of their products and dossier compilation for the Kingdom of Saudi Arabia market. Client’s biggest product portfolio, baseline eCTD submissions for already submitted paper and NeeS formats, complex data etc. were some of the initial roadblocks Freyr had to address.

Read this case study to decode how Freyr has overcome complexities and perfomed end-to-end gap analysis for successful compliance.