GBIOLOGICS

• Product development strategy planning

• Description of regulatory expectations

• Provide guidance on interactions with
regulatory agencies

• Assessment/Planning for Nonclinical
and Clinical Trials

• IND Evaluation/Preparation

• Support for Regulatory Meetings
Planning

•Evaluation/Preparation of Dossiers

•Review of Data/Document

•Support for Pre-NDA/BLA Meeting
Planning

• Licensing in the biopharmaceutical field refers to the comprehensive task of transferring (out-licensing) or acquiring (in-licensing) products and underlying technologies (platform technologies) that have been developed or are under development between domestic or foreign pharmaceutical companies, biotech companies, or research institutes.

• In Country Caretaker Agency for Overseas
Company's Expansion into the Domestic
Market

• Field Audit

• Clinical Trial Audit

• General Regulatory Compliance Support