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Our team of experts posseses in-depth knowledge and extensive experience in a comprehensive range of professional services: regulatory support (for pharma and medical devices, incl. PRRC), pharmacovigilance services (incl. QPPV), quality assurance activities (incl. 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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