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
Communication
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
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