Regulatory Affairs

Services scope:

Evaluation and submission of the dossiers

Tracking evaluation progress and regulatory information

Development of the registration strategy

Application of the CTA and IDL

Why choose us:

We understand the client demands and the importance of sound regulatory strategies within a complex and ever-changing environment.

More than twenty professionals formed the RA team. Our RA professionals are not only familiar with the CFDA laws and regulations but also have broad therapeutic expertise and    experience. They have the professional spirit to support our client demands throughout the entire programme lifecycle.

With a network of international experts and a client focused approach, we are committed to delivering superior quality regulatory services that enable our clients to expedite drug development programmes. In addition, we utilize a well established network of international consultants.

We are flexible to the individual requirements of our clients and tailor our services to meet our clients’ short- and long-term needs.

We work in partnership with our clients to maximize opportunities and meet key milestones on time and on budget.

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