The clinical development regulatory affair team is professional and experienced. We are proficient in regulatory affairs in FDA, NMPA, and EMA, and have deep understanding of local regulatory requirements. With strong project management and consultant team, we can provide one-stop regulatory solutions to support hundreds of registration projects successfully.

What we do

Regulatory Strategy and Consultation

Customized strategy design and implementation guidance

Consultation, analysis and assessment for each case

Deal with difficulties in each stage of the project

Explore and develop the optimal registration pathway based on RWD

Rapid gap analysis and feasibility assessment of various applications before submission

Specific guidance to respond to questions raised by NMPA


Application, preparation and organization of various CDE communication meetings

Other communication meetings with regulatory authorities

Registration Application

Preparation, compiling and submission of IND /NDA/ ANDA /Supplementary application dossiers for domestic and imported drugs

Project management and following up during the whole application process

Coordination of the review and inspection of specification

Assist in site audit

Assist in preparing and submitting the annual report