Writing application materials

Review the reports of pharmacy, pharmacology, pharmacokinetics and toxicology studies to make them meet the application requirements; prepare a full set of IND application materials including summary data, pharmaceutical data, pharmacology and toxicology data, clinical research data and investigator's manual.

Follow-up and communication of the declaration process

Prepare technical materials required for preclinical communications and review panel meetings.

Follow up the whole process of the application, communicate with the Drug Evaluation Center and the Central Inspection Institute professionally and efficiently, so as to make the review process smooth and without delay.

Participate in the defense of the review panel meeting.

Develop countermeasures and prepare for answering questions.

Design layout of biological products plant

Establishment of quality management system for biological products

GMP self-inspection related services