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
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
Regulatory strategy and consultation
Design and optimization of regulatory and R&D strategy for several innovative drugs, orphan drugs and simultaneous development projects between China and US.
Pre-clinical dossier assessment and expert consulting meeting for several oncolytic virus and CAR-T projects, etc.
Regulatory consulting service of Pre-IND and IND for several innovative chemical drugs and biological products.
Regulatory strategy and consulting service for 100+ imported drug projects.
Pre-IND meeting for several innovative chemical drugs and biological products.
Pre-IND meeting for several oncolytic virus and CAR-T projects etc.
Several type III CDE communication meetings.
Communication with CDE about reducing subject size of clinical trials for rare diseases based on big-data technology and analytics.
IND (including MRCT) and supplemental application service for several innovative chemical drugs and biological products.
Category 5.1 and 5.2 ANDA/NDA application service for several imported chemical drugs
IND application service for several oncolytic virus products.
Services for inspection of several imported chemical drugs, BE filing and drug tests etc.
Clinical trial application for imported biosimilar.