…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.
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.
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.
Our regulatory team do product information translations between English and Swedish, and vice versa.
Before publishing of marketing / promotional material, it needs a review for compliance with the ethical code of the pharmaceutical industry. The RegFile team will support you with:
– Review of all types of promotional materials for the Nordics, against applicable ethical code and legal requirements.
– Review and guidance on Nordic marketing activitites and collaborations with health care professionals and patient organisations.
– Tailored in-person training on local requirements and codes.
The RegFile team provides clear and concise feedback to support your business decisions.
The eCTD dossier is to be compiled and published by the book with a dedicated software. Let us do that for you.