Regulatory Services

We will design tailored step by step strategy based on your requirements from eCTD dossier compilation, expert reports preparation, to filling and support through the whole registration process within the EU.

Our team of experts has the experience and knowledge so they can always work in line with the current legislation and requirements in order to meet deadlines and restrictions of the local and international regulations. The team can cover national, DCP and MRP registration procedures of wide range of product starting with biosimilars, vaccines, generics, either prescription or OTC products, ensure fast approvals for medical devices, food supplements, cosmetics or biocidal products.

We can manage every phase of a product’s life cycle:

  • Custom strategy for your product portfolio
  • Comprehensive advice on the impact of emerging and existing legislation
  • eCTD compilation and publishing
  • Expert reports and high-quality translations
  • Support in preparation of the documentation
  • Artworks and labelling