Country of client: North America
Project: Medical writing of Modules 2.4, 2.5, 2.6 and 2.7 for Iron Dextran Project
Summary: We were entrusted to create Modules 2.4, 2.5, 2.6 and 2.7 for a large generic company to make sure that their dossier was ready for registration.
Issues: The client faced an issue with the health authority, as they had changed the molecular weight of the product. This needed to be justified by literature to support the safety and efficacy and to prove that the lower molecular weight would not change the safety and the efficacy of the product. Issues:
Solutions we gave:
Our Medical Writers searched and provided the most relevant articles that could support this claim and the dossier was successfully created. We reviewed the guidance for using literature data and performed a broad search in order to find the most recent and relevant articles of the product. Then the articles were filtered to safety and efficacy articles. We then selected the most relevant articles that could support the lower molecular weight without affecting the safety and efficacy profile of the product. The project was accomplished and successfully submitted to the health authority in Canada.
We understood that the way to address the issues with this project were to go back to our literature screening and see if firstly we could justify the safety and efficacy of the product, rather than having to create additional work and delay for the client unless it was necessary. Our experience told us that we would find sufficient information to safely prove what we believed in the end to be true. The result for the client was minimal cost and time disruption and eventually a successful Module 2!