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Generic Drug

SERVICE AREAS & COMPETENCES

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