At Idifarma we are specialists in the 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.
We have experience developing generic and innovative drugs, as well as OTC and hybrid products. We can develop according to ICH Q8 requirements to comply with FDA authorities.
We have developed over 100 products for our clients in a variety of dosage forms:
- Oral solids: capsules and IR/MR tablets.
- Oral liquids: solutions and suspensions
- Injectable drugs: solutions and freeze-dried
- Topical use drugs
We are organized as a company to adapt to the needs of our clients and to efficiently manage their projects.
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.
- Technology transfer to the final manufacturing site (client’s facility or CMO)
- GMP manufacturing of the product.
- Quality control.
- ICH stability studies.
- Clinical trial supply.
- Prepare and submit the registration dossier.