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, or help with selected issues. For early development regulatory affairs, we collaborate with our brilliant colleagues within the CTR group.
During drug development…
…we support you with the writing of complex summaries and expert reports such as briefing documents for scientific advice, or documents for clinical trial / investigational new drug applications (CTR / IND) such as Investigator’s Brochure (IB), investigational medicinal product dossier (IMPD). All in consultation with scientific / therapeutic area experts.
Marketing authorisation applications &
New drug applications
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 and coordinate the approval procedures.
Post-approval regulatory activities
We support you with a wide range of regulatory affairs related activities.
As for variations, we classify them as well ass 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.
Product information translations
Our regulatory team do product information translations between English and Swedish, and vice versa.
Marketing material compliance
Before publishing of marketing / promotional material, it needs a review for compliance with the ethic code of the pharmaceutical industry. Please let us assist.
The eCTD dossier is to be compiled and published by the book with a dedicated software. Let us do that for you.