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Interdos is a service provider for pharmaceutical and medical-related companies. Our team of experts possesses in-depth knowledge and extensive experience in a comprehensive range of professional services, including regulatory support (for pharmaceutical and medical devices, including PRRC), pharmacovigilance services (including QPPV), quality assurance activities (including QP and RP), and laboratory services (EU QC release).
Regulatory Affairs
Advice on regulatory strategy and EU legislation
Regulatory due diligence
Dossier preparation, submission (national, MRP, DCP), maintenance and variations
Development and updating of eCTD registration dossiers
Compilation of Modules 2.3, 2.4 and 2.5
Compilation of labels, leaflets, SmPC and mock-ups
Readability testing of Patient Information Leaflets
Assessment of registration dossiers
Applications for scientific advice
Change of Legal status
Biological medicinal products and biosimilars
Medical devices in compliance with the Medical Device Regulation
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