- Pharmaceuticals including Oligonucleotides, HP-API
- Generics
- Medical Device
- Biotechnology
- Biologics
- Combination Products
- Cell Therapies / ATMP
- Medical Diagnostics
Since 1999, Shiba Biotechnology has been involved globally in addressing client requirements with interpreting and applying evolving biologic and drug regulations. Shiba’s team consists of multidisciplinary subject matter experts with experience in USFDA, EMA and JP regulations having enabled drug development process encompassing GXP and ISO requirements inclusive of non-clinical and clinical studies. This integrated approach has provided applicable recommendations to the clients.