Stepping Stone provides regulatory support and consultancy to ensure smooth and fast track authorisation process in the European Union and Eastern Europe.
Our experienced team have a solid background with regulatory affairs and work with you to achieve compliance including the most suitable registration strategy for your requirement.
Preparing dossiers and submission within the EU
We can assist with the preparation and submission all types of applications to EMA either through eSubmission Gateway or using CD/DVD-formatted discs.
We will help you prepare the dossier in-line with all the guidelines and requirements set by the EU including that all the standards regarding structure, content, terminology and layout are met.
Seasoned in-country local support
Think of Stepping Stone as your local guide – a partner to accompany you through all the stages of the marketing authorisation process. We can act as a liaison between the local regulatory authorities and your company and help you implement all the recommendations given by Product Information Quality review group during the pre-opinion phase of the authorisation process. Our seasoned consultants will also prepare the necessary documentation explaining why certain changes could not be implemented.
A representative can attend meetings on your behalf with the Agency foreseen by the procedure to allow a smooth dialogue between the parties.
We can translate SmPCs, PILs and labelling materials into all EU languages as well as Icelandic and Norwegian.
All changes and comments made to the source documents by the Agency will be communicated down to our linguistic teams to be implemented across all languages to facilitate a smoother post-opinion phase.
Assistance with renewing Marketing Authorisations
We view your relationship with Stepping Stone as a long term partnership and support is not limited to the initial MA. As such our service can also assist MAHs to renew Marketing Authorisations.