Q: What specific services are covered under the Dietary Supplement Compliance Set-Up package?
A: Our services include regulatory guidance and strategy development, labeling and documentation assistance, ingredient and claims analysis, quality assurance and control, staff training, post-market surveillance, and ongoing support. We help ensure that your products meet all FDA and DSHEA requirements.
Q: How can you determine if my product complies with FDA regulations?
A: We perform a thorough review of your product formulations, ingredients, and proposed claims against FDA regulations and DSHEA requirements. We also assist in developing a compliance strategy and reviewing your product labels to ensure they meet all regulatory standards.
Q: What steps are involved in reviewing and finalizing product labels?
A: Our label review process involves creating a compliant label template, including the Supplement Facts panel and other required information, followed by revisions based on your feedback. We ensure that all labeling meets FDA guidelines and is ready for market.
Q: What methods do you use to verify the safety and compliance of ingredients?
A: We review the ingredient list against FDA regulations and safety databases, ensuring that all components are approved for use in dietary supplements. We also assess any potential risks associated with the ingredients.
Q: What training is offered to our staff?
A: We provide training on dietary supplement regulations, labeling requirements, and compliance practices. This includes creating educational materials and conducting training sessions tailored to your team’s needs.
Q: What steps do you take to ensure quality assurance and control?
A: We assist in implementing quality management systems and protocols to maintain product consistency and safety. This includes auditing manufacturers to ensure they comply with Good Manufacturing Practices (GMP).
Q: What does post-market surveillance involve and why is it important?
A: Post-market surveillance involves monitoring product performance, customer feedback, and adverse events after the product is on the market. It’s crucial for ensuring ongoing compliance and addressing any issues that arise.
Q: How will you keep us informed about regulatory changes?
A: We stay updated on regulatory changes and inform you of any new requirements or standards that may affect your products. We also provide guidance on how to adapt to these changes to maintain compliance.
Q: How long does it take to complete the dietary supplement compliance set-up?
A: The timeline varies depending on the complexity of the product and the extent of the services required. Generally, the process can take several weeks to a few months. We will provide a detailed timeline during our initial consultation.
Q: What are the steps to begin working with InterlinkIQ?
A: To get started, contact us to schedule an initial consultation. We will discuss your needs, gather necessary product information, and outline a plan of action. From there, we will begin the compliance set-up process tailored to your specific requirements.
If you have any more questions or need further clarification, feel free to reach out to us directly. We're here to help ensure your dietary supplement products meet all regulatory requirements and succeed in the market.
