Clinical Approval Development

Full-process service for the development of IND clinical approval documents for innovative drugs in China and the United States

XXXX001: Submitted PIND on August 17, 2021, and received a reply on September 15.

XXXX001: Submitted PIND on January 27, 2022, received response on March 11.

XXXX006: PCC screening phase in progress

Declaration Category

• Class 1 innovative drugs
• Class 2 improved new drugs
• Class 3, Class 4 generic drugs
• Consistency evaluation
• Supplementary application

Serving Form

• Oral formulations: tablets, capsules, granules, oral solutions/suspensions, syrups
• Injectable preparations: injection, sterile powder for injection, concentrated solution for injection
• External preparations: ointments, creams, tinctures
• Other formulations: eye drops, sprays, sustained-release formulations

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