Regulatory Affairs

At CSC we understand you need a trusted partner to help you bring your products to market efficiently as soon as possible.

We have a professional team of regulatory affairs responsible for collecting and analyzing the evolving local regulatory and their impact on the product development and registration.

As your full-service regulatory partner, we provide comprehensive registration strategies covering the whole lifecycle of project implement and regulatory consultation services to minimize risk and maximize benefit.

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Regulatory Affairs

At CSC, we understand that you need a trusted partner to support your products access to market efficiently and earlier as possible.

At CSC, we understand that you need a trusted partner to support your products access to market efficiently and earlier as possible.

We have a professional team of regulatory affairs responsible for observations and analyses of local and US regulatory evolution that might potentially impacts on the development and registration of your products.

As your full-service regulatory partner, we provide comprehensive registration strategies covering the whole lifecycle of a project implement and regulatory consultation services to minimize risk and maximize benefit.

Our abundant experiences:

Since new Provisions for Drug Registration & Requirements for Registration Classification and Application Dossiers came in to force in 2020, we have undertaken more than 50 registration projects and several consultation projects. Detailed information of our projects experience are as follows:

Mainly are innovative and modified new drugs

Domestic and overseas imported registration and post-approval maintenance

Sino- US gap analysis, registration and post-approval maintenance

Covering Pre-IND, EOP1, EOP2, Pre-NDA, Post-approval, Pre-ANDA communications with authorities

Covering IND, NDA, ANDA, supplementary application and DMFs within variety applications

Including chemical drugs, antibody, recombinant proteins, oncology vaccines, PDC, etc.

Our outstanding advantages:

Numerous project experience

Efficient project management

Abundant registration resources

One-stop full-life cycle services

Professional Sino-US team

Cross-functional coordination
Our Registration services:

Registration strategy development

Various registration types throughout whole lifecycle development stages

Registration dossier preparation and submission

eCTD formatting, publish and submission

Review communication and support

Post-approval and annual maintenance

Sino-US gap analysis, risk assessment and strategy

U.S. agent representation and FDA submission essential resources
Our Regulatory consultation services:

Regulatory intelligence research, tracking and assessment

Regulatory consultation, interpretation and insight

Regulatory strategy development

Specific product registration support

Regulatory training

Customized solutions