Dietary Supplement Regulatory Consulting Services
Throughout the past 10 years, the dietary supplement industry has been under increasing scrutiny regarding the safety of its products. Federal bodies and quality bodies, Therefore, companies aiming to produce and distribute natural and synthetic dietary supplements to the public must follow strict guidelines and meet various requirements to verify that their product is both safe and backs up each of its health claims.
JJCC Group is a leading regulatory consultant agency in the life science industry. We serve companies across the entire United States, helping organizations in the dietary supplement industry adhere to the Dietary Supplement Health and Education Act (DSHEA) and various other federal and industry-specific regulations.
Nowadays, more than ever, it is critical to ensure that each stage of your dietary supplement’s creation – from safety programs to labeling, to dispersion and sales, to manufacturing and distribution – is pristine.
We will help your company develop thorough regulatory strategies for your dietary supplement product. We’ll also assist with the following:
- Supply chain management.
- Dietary supplement labeling.
- Federal Food and Drug Administration (FDA) requirements.
- FDA audits.
- Food safety programs set up and implemented.
- Submission of New Dietary Supplement Notifications.
- Generally Recognized as Safe (GRAS) submissions.
- Employee training.
- Clinical trials.
- New Dietary Ingredient (NDI)
- Adverse event reporting.
Dietary Supplement Labeling & Substantiating Health Claims
JJCC Group advises firms on their manufacturing, marketing, or distribution process of dietary supplements. JJCC Group will design and conduct clinical trials for raw materials or finished products if your company’s intent is to prove the efficacy and safety of your supplement.
Many manufacturers that do not comply with labeling guidance will experience various roadblocks when trying to gain FDA approval of their product. JJCC is meticulous in designing comprehensive clinical studies to validate any claims made on your dietary supplement labels. JJCC Group consultants will ensure that each dietary ingredient label and insert adheres to all necessary FDA regulations to further minimize your organization’s risk and optimize your product development journey.
Current Good Manufacturing Practice (CGMP) Regulatory Consulting
JJCC Group helps you perfect each stage of your dietary supplement manufacturing, from packaging, labeling, and holding operations. We help clients develop and comply with regulations regarding the 21 CFR part 111. If you are seeking guidance, advisement, or assistance in bringing your dietary supplement to full fruition, reach out to JJCC Group. Our consultants will help you optimize your internal processes and bring your product to the United States market – without typical compliance roadbumps.