Regulatory affairs is a term that includes a lot. But we dare say we cover most of what is included in the term as from the late development phase and onwards, for pharma products. We have highly experienced regulatory specialists who can act as your regulatory affairs department, act as regulatory manager or project lead for a certain product, or help with selected issues, such as local requirements. Either way, we are here to help.
We support you with general regulatory affairs and procedure management.
We also write and coordinate the writing of all modules of your dossier. We coordinate manufacturing (CMC) matters.
And of course we help you put the modules together and publish them i eCTD format.
We submit the applications, coordinate the response rounds, authority corresponcence and approval procedures.
We support you with all the post-approval regulatory affairs related activities such as variations, renewals and PSURs.
As for variations, we classify them as well as write and compile all parts of the dossier. We update your product information. And of course we do the eCTD publishing, the submissions and the procedure management.
Post-approval regulatory activities may also include local database updates, compendia updates, mock-up reviews, promotional material reviews etcetera.
We will help you reach your milestones and facilitate collaboration with the agencies during your product´s continuous development.
RegFile AB
Eklundshovsvägen 1G,
752 37 Uppsala, Sweden
info@regfile.se
