Service Areas
Project evaluation and registration strategy establishment
Helping clients work out overall schemes and plans to establish the target product profile (TPP) and the target product quality profile (TPQP)
Supervision of proposal generation according to the idea of QbD
Organization of milestone review and reporting to help clients in risk assessment
Support of technology transfer
Management of samples and documents to make the application in accordance with regulations
Preparation of submission documents
Preparation for on-site inspections
WHY IS PRE-CLINICAL SUPPORT NEEDED?
Sundia’s generic drug development solutions utilize our vast generic drug development expertise that helps our clients from project establishment to ANDA filing. Sundia has helped hundreds of clients complete successful generic development projects and product launches. Sundia has solved many of the development problems in meeting regulatory standards. The data we have produced has been reviewed favorably by the CFDA. There were no violations in the data we have produced since the start of the business. Sundia has successfully completed product development, eliminating risks and ensuring registration success
Proven track record
| Indications | Classification | Dosage | Filing Stages |
|---|---|---|---|
| dermatitis | Chemical drug, class 6 | cream | Approved |
| cancer | Chemical drug, class 5 | capsule | Approved |
| hypercholesterolemia | Chemical drug, class 6 | tablet | Approved |
| HBV | Chemical drug, class 6 | tablet | Approved |
| anaesthetics | Chemical drug, class 6 | cream | ANDA filing (technical evaluation) |
| asthma | Chemical drug, class 6 | drug substance | ANDA filing (technical evaluation) |
| asthma | Chemical drug, class 3 | drug substance | Approved |
