Post-approval

A product should pay its R&D costs back once on the market. Manufacturing costs can be reduced by improvements in efficiency and product labelling can be enhanced by additional claims – all requiring variations to your Marketing Authorisation. Importantly, the product must remain compliant (CMC, labelling) throughout its life. Let our experienced team reduce the strain on you.

We can help you in your post-approval activities by offering a full range of services:

  • Variations, renewals, PSURs, transfer of ownership applications (preparation, submission and follow-up)
  • CMC-compliance (Module 3), review of existing dossiers vs. manufacturing site practice and current regulatory requirements
  • SPC, leaflet and labelling (preparation, review, submission and coordination of translations)
  • Advice on data requirements for variations and variation classification
  • Advice on variation filing strategy (e.g.grouping, worksharing)

Interested in our service? Let's talk