product registration

We offer full support at the stage of registration of medicinal products

• preparation of documentation in CTD format and submission of dossier to registration offices
• active monitoring of the national and European registration process (DCP, MRP, changes)
• full support in contacts with national registration agencies and EMA, including scientific advice
• preparing responses to comments from registration agencies
• coordinating registration procedures in national, mutual recognition and decentralized procedures (NR, MRC and DCP)
• preparation of information forms

We offer full support as part of services in the dietary supplements and cosmetics sector

• development of the Finished Product Specification (supplements) or product card (cosmetics)
• support for the design process of labels, cartons, tubes, etc.
• preparation of documentation necessary for the notification process, including reports from external institutions
• notification (assistance in reporting to relevant offices)