SOLUTIONS

Solution

Medical - Registration Affairs

Release time:

2020-09-10 13:50

Source:

Customized services, a trusted partner Well-versed in domestic and international laws, regulations, and technical guidelines: Accurately grasp the current review philosophies and cutting-edge information from NMPA, FDA, and EMA, maintaining forward-looking insights to provide clients with feasible strategies and solutions. Embedding registration-outcome-oriented and closely integrated strategies into clinical solutions: We have a deep understanding of local culture and have maintained excellent, open communication channels with regulatory authorities—from CFDA through NMPA—accumulating extensive experience and resources in both technical and regulatory matters. Gained drug registration experience from over 200 projects: Our registration strategies have been recognized by NMPA; several emerging biologics—including cell therapies and oncolytic viruses—have received accelerated reviews, facilitating conditional marketing approval for rare-disease projects, and cell therapy projects have steadily increased year after year. Efficient clinical study design—effectively controlling drug development costs: Thanks to our specialized medical team and experienced expert panel’s advanced strategy formulation and scientific design, we’ve participated in the evaluation of nearly 1,000 drug candidates, with innovative drug services accounting for over 60% of our work in the past five years.
Medical - Registration Affairs
Medical - Registration Affairs

Customized services, a trusted partner.

  • Familiar with domestic and international laws, regulations, and technical guidelines:

Accurately grasp NMPA 、 FDA 、 EMA Stay abreast of current review concepts and cutting-edge information, maintain forward-looking insights, and provide clients with viable strategies and solutions.

  • A strategy embedded in clinical solutions that is registration-results-oriented and closely integrated:

We have a deep understanding of local culture, starting from... CFDA To NMPA Throughout this period, we have maintained a smooth and effective communication channel with the regulatory authorities and have accumulated extensive experience and resources in both technical and regulatory matters.

  • From 200 Gained drug registration experience in a project:

Registration policy obtained NMPA It is recognized that several emerging biopharmaceuticals, including cell therapies and oncolytic viruses, are undergoing accelerated review, which is helping rare-disease projects gain conditional approval for market launch. The number of cell therapy projects has been increasing year by year.

  • Efficient Clinical Study Design - Effectively control drug development costs:

Thanks to the advanced strategy development and scientific design provided by a specialized medical team and a seasoned expert panel, nearly ... drugs are being evaluated. 1000 Item: The proportion of innovative drug services over the past five years has reached 60% The above.

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