Dossier Preparation Services
From pharmaceuticals to food supplements, from herbal medicines to biocidal products — we offer complete regulatory dossier preparation for all products that meet relevant eligibility criteria.
✅ Preparation of e-CTD registration dossiers
✅ Development and revision of SmPC (Summary of Product Characteristics) and PIL (Patient Information Leaflet)
✅ Preparation of variation application dossiers
✅ Renewal dossier compilation
✅ Regulatory submissions for traditional herbal medicinal products
✅ Food supplement registration files
✅ Dossiers for biocidal products
✅ Licensing support for veterinary medicinal products
We support you at every step — with compliant, timely, and reliable documentation, tailored to your product.