Medical Writing

Medical documents are written by several docotrs of pharmacy who specialize in the fields of medicine and biopharmaceuticals. From pre-clinical to clinical, and finally to the process of approval, we provide scientific and strategic services to cover various products. To meet the required documents, we have extensive experience in small molecule drugs, botanicals, cell therapy, biological agents, gene therapy, combined products of drugs and medical materials, vaccines, etc.

• FDA Pre-IND/Pre-IDE Meeting

• FDA End of Phase II Meeting

• FDA Pre-NDA/Pre-BLA Meeting

• CDE (TW) Consulting Meeting

• TW and US Drug Regulation Consultation

• Manufacturing Control and Pre-clinical Trial Consultation

• ICH CTD common format writing and eCTD Compiling

• Gap Analysis for IND Filing

• Response to Authorities

• IND IND maintenance and annual report writing

• Maintenance and Annual Report

• Investigators’ Brochure

• Clinical Protocol

• Clinical Study Report

• Data and Safety Monitoring Board Charter

• Safety Management Plan

• Bridging Study Evaluation

• Medical Monitoring