A: Nutraceuticals are products derived from food sources that offer health benefits beyond basic nutrition, including dietary supplements and functional foods.
Q: Why is compliance important for Nutraceuticals?
A: Compliance ensures that products meet FDA regulations and industry standards, helping to guarantee consumer safety and avoid legal issues.
Q: What does the compliance set-up process entail?
A:The process includes a regulatory assessment, documentation support, labeling compliance, quality management system implementation, staff training, and preparation for audits.
Q: How do you identify compliance gaps?
A: We conduct a comprehensive review of your current products, practices, and relevant regulations to pinpoint areas that require improvement or adjustment.
Q: What kind of documentation will I need?
A: Essential documentation includes product specifications, safety data sheets, manufacturing records, and standard operating procedures (SOPs).
Q: Will you help with product labeling?
A:Yes, we provide guidance on creating compliant product labels, ensuring proper ingredient listings and allowable health claims.
Q: How can you help with training my staff?
A: We offer customized training sessions focused on regulatory requirements, compliance procedures, and best practices in the nutraceutical industry.
Q:What is a Quality Management System (QMS)?
A: A QMS is a structured system that ensures consistent product quality and compliance with regulations through monitoring and quality control measures.
Q:How do you prepare for FDA inspections?
A:We develop a checklist and conduct mock audits to help ensure your operations are compliant and ready for any regulatory scrutiny.
Q: What happens after the compliance set-up is complete?
A:We schedule follow-up reviews to monitor compliance status, address emerging issues, and provide updates on regulatory changes, ensuring ongoing adherence to standards.
Elevate your nutraceutical business with our tailored compliance strategies!
