Product & Process Validation
Research and development to get a safe, effective, stable and high quality, medicinal product.
Pilot and production validation process.
Test and validation batches are manufactured while the stability profile of the final product is tested.
Design, submit and carry out the clinical trials, after its validation by scientific advice, in order to demonstrate the safety and eficacy of the product in humans (Proof of Concept).
CE Mark & Approval
The Dossier could be a CTD (Common Technical Dossier) for medicinal products or FT (Technical File) for Medical Devices.
Dossier it is submitted to the corresponding authority in order to obtain the marketing authorization.
Scale-up and Supply of the products ensuring reliable and timely delivery.