GBIOLOGICS

●Set-up product development strategy

●Explanation of regulatory expectations

●Guidance on interactions with regulatory agencies

●Non-clinical and clinical study plan/review

●IND Dossier evaluation/preparation

●Assistance in planning regulatory meetings

●Dossier evaluation/preparation

●Data/document review

●Assistance in planning pre-NDA/BLA meetings

●Out-licensing/In-licensing of biological products or platform technologies, developed or under development, between domestic companies/institutions or between domestic and overseas companies/institutions

●In-country caretaker for foreign companies, Due diligence audits, Clinical trials audits, General regulatory support