In Idifarma, we are specialized in comprehensive management of pharmaceutical development projects. We carry out all the experimental, documentation and consulting work, from finding a supplier of active substance to the elaboration of the registration dossier of a pharmaceutical product.
We cover a wide range of products, dosage forms and technological solutions.
Each development project, whether partial or complete, is commissioned to a project manager, who centralizes all communications with the client and is responsible for meeting deadlines.
Once the scope and timetable of the project are agreed upon with the client, we perform a literature review, which allows us to know everything published about each product and anticipate potential problems that may affect the future development of the project.
After the formulation and analytical development, we can manufacture batches for clinical trials in our GMP plant, perform quality control of finished product and ICH stability studies and we can even manage the logistics of the clinical trials. Finally, our Regulatory Affairs team is able to prepare and submit the registration dossier.