Comprehensive Regulatory Consultation
Our RA team offers integrated regulatory consultation services, encompassing project feasibility assessments and strategic evaluations. By conducting thorough gap analyses, our experts ensure adherence to diverse regulatory requirements across countries and regions, optimizing multinational submission processes and license programs.
Strategic Communication with Authorities
Our team excels in official communication with regulatory authorities throughout key milestones such as pre-IND, EOP, and pre-NDA stages. This includes written responses, audio/video meetings, face-to-face interactions, and scheduling on-site regulatory inspections. Such strategic engagement ensures efficient progression through regulatory pathways, facilitating timely approvals and compliance.
Global Regulatory Submissions Expertise
Our company specializes in preparing and submitting regulatory packages to prominent agencies like China NMPA, US FDA, and others, covering IND, NDA/BLA, ANDA, DMF, ASMF, supplementary registrations, and renewal processes. Our comprehensive approach spans the entire product lifecycle, including clinical development stages such as DSUR, SUSAR, CMC, and non-clinical and clinical amendments.
Lifecycle Management and Compliance Support
Beyond initial submissions, our RA team tracks regulatory progress and status, ensuring ongoing compliance and lifecycle management. This includes Trial Master File (TMF) management, eCTD validation, publishing, and project lifecycle maintenance, enhancing efficiency and regulatory robustness.
Other Services and Strategies
Our company offers specialized services such as Orphan Drug Designation (ODD) applications, DMF registrations for drug substances and excipients, and seamless integration with clinical trial databases such as clinical.gov (China and US). Our expertise extends to preparing non-clinical overviews and summaries based on rigorous study reports, ensuring comprehensive regulatory documentation.
