Regulatory Compliance

The ever-changing regulatory requirements in the United States and worldwide have produced one of the biggest challenges to the dietary supplement industry.  As the implementation of the dietary supplement cGMP rolling out in the final stage, FDA’s inspection is expected to gear up.  Continuum Partner Consulting specializes in regulatory compliance, especially in dietary supplement cGMP compliance, which can help you navigate through the regulatory issues.

Our experts have decades of experience in dealing with the FDA, including drafting the original dietary supplement cGMP for FDA, training FDA inspectors for dietary supplement cGMP inspection, and handling FDA audits.
 
With understanding of the FDA’s interpretation of the cGMP requirements, our experts offer practical and cost-effective solutions to improve product safety, quality, and operation efficiency. 
Our services include cGMP Turn-Key Services, Audits, SOP Development, Training, Vendor Qualification, Expert Witness Services, and Label Review.

cGMP Turn-key Services
Developing and implementing a dietary supplement cGMP program requires tremendous resources and experiences.  Continuum Partner Consulting offers turn-key services from audits, gap analysis, SOP development, training, implementation, to continuous improvement.

Audits
We conduct dietary supplement cGMP audits, good laboratory practice (GLP) audits, mocked FDA audits, hazard analysis and critical control point (HACCP) audits, supplier audits, quality system audits/evaluation, and contract manufacturer audits.

SOP Development
We develop SOPs to save organizations time, money, manpower, and effort.  When created and used properly, SOPs will maximize productivity and deliver outstandingly reliable performance every time.  Our consultants help you to develop SOPs that are practical and easy-to-follow.

Training
We offer a full range of public training, workshops, and webinars to enhance your capabilities and efficiencies in cGMP, quality systems, and other regulatory compliance in the US, China, and other countries. We provide effective on-site training at your facilities customized to your needs.

Supplier Qualification
Qualifying suppliers is the front line to prevent adulteration and contamination in products, and to ensure that specifications are met for the identity, purity, strength, and composition of products.  The FDA dietary supplement cGMP not only requires manufacturers to have a supplier qualification program, but also emphasizes on-site audits of ingredient suppliers as part of the program.
 
We develop and implement supplier qualification programs for our clients focusing on supplier/manufacturer relationships, audits, supply agreements, quality agreements, analytical methods, change controls, training, and risk management to ensure product safety and regulatory compliance.  We also use supplier qualification programs from third-party certification companies as specified by our clients.

Expert Witness
When litigation arises in regulatory compliance, you can rely on our technical experts’ advice, testimony, discovery, analysis, and fact findings which are vital to winning your case.  Our experts are highly experienced, knowledgeable, and credible in the industry and subject matters.
 
Label Review
We offer comprehensive label review on food and dietary supplement products to ensure compliance to FDA food and dietary supplement labeling regulations.