China (CFDA) Compliance Solutions

Leverage our expertise in Food Regulatory Advisory, Cosmetic Regulatory Advisory, Chanel and Distribution Advisory, and Feed Regulatory Advisory to adhere to CFDA Compliance.

CFDA Regulatory Compliance

The China Food & Drug Administration (CFDA) is a government entity, responsible for regulating drugs, medical devices, and healthcare services. Extensive clinical data and in-country testing of most medical devices are mandatory by The National Medical Products Administration (NMPA), previously  CFDA.  NMPA ensures that organizations in China operate their business ethically and fairly. Adhering to these regulations is challenging even for experienced professionals. 

With that in mind, Quality Smart Solutions is committed to assisting manufacturers, distributors, importers and sellers meet the regulatory compliance of CFDA and NMPA. Our experts will help you by conducting a detailed assessment of the compliance requirements for testing and clinical trials for your healthcare products, medical devices and assist with registration. 

How We Help You

Compliance risk is a threat to organizations. We set a well-defined compliance process to mitigate your organization’s risk of violating these regulatory standards. When you partner with us, you will get assistance from retired CFDA experts to discover compliance risks and have sustainable growth. We make sure you adhere to all pertinent laws and rules. We help with:

Services Offered by Quality Smart Solutions

We assist you in managing CFDA regulatory compliance. Our China advisory services include Regulatory strategy and planning, Regulatory submissions and translated eCTD, Strategic risk and compliance management, Clinical development planning and execution, Market Access Support and Commercialization strategy. Holding more than a decade of experience, we have carved a niche in CFDA regularly compliance working with authorities. 

Product Strategy & Classification

Our experts will evaluate risks associated with internal and external factors of your products, followed by planning strategies and product classification to determine in which CFDA Regulations your products come.

Compliance Consulting

Our team consists of former CFDA officials who review your compliance aspects to be compliant with the China Food & Drug Administration’s requirements for medicines, healthcare products, and Cosmetics.

Regulatory Compliance

We will help you by providing complete CFDA Regulatory Compliance solutions in China to enter the Chinese marketplace and establish your Cosmetics, Medicines, Healthcare products and Homeopathics business.

Expert Guidance

Get guidance about TGA regulations, prescription medicines, biotech medicines, generic medicines, dossier to meet TGA regulations and acquire certification to enter the Australian marketplace without any compliance issue.

Auditing & Inspection

Our CFDA compliance professionals will inspect and audit materials, labelling, packaging and quality of your products. The purpose to ensure you follow all the norms and standards of CFDA Regulations.

Application Assistance

Get support to accomplish the documentation process, application process and, licensing process for product registration. We help domestic and international organizations to comply with CFDA Regulatory Compliance.

Need Assistance for CFDA Compliance?

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