Smooth Drug Development provides services for full registration programs of generic biotechnology drugs (biogenerics or biosimilars).
To register a biosimilar product, within the registration dossier it is necessary to provide producer`s own data on pre-clinical and clinical studies.
Clinical studies are conducted in two stages:
- A safety study. Such studies are conducted as phase I studies in healthy subjects, or in patients depending on the product safety profile.
- An efficacy study. Such studies are conducted as phase III studies.
We are fully aware of all the difficulties that might occur during pre-clinical studies, study design preparation, clinical studies, and drug registration.
We have performed clinical trials with biosimilars in anemia, multiple sclerosis, viral hepatitis, as well as in oncology and rheumatology.
Smooth Drug Development is a CRO in Russia and CIS offering the full spectrum of solutions for clinical studies of biosimilars since 2013.