As the skincare industry grows and evolves, regulatory compliance has become a crucial concern for brands looking to launch new products. With numerous laws in place to safeguard safety and efficacy, brands may find it difficult to navigate the regulatory landscape. A Contract Research Organization (CRO) can assist with this.
A CRO is a third-party organization that provides research services to companies who need clinical research for their products. At Citruslabs, we specialize in providing these services to wellness CPG brands. In the skincare industry, a CRO can help with a range of services, including regulatory compliance.
Here are some ways a CRO can help your skincare brand achieve regulatory compliance:
Keeping up with changing regulations
Regulations are continuously changing, making it difficult to stay current. A CRO will assist by keeping you updated on legislation changes. This can involve advising on labeling requirements, ingredient limits, and other regulations that may have an influence on your brand's products. This information is shared through newsletters, educational webinars, and working with a CRO directly, especially when you have questions about your specific product.
Conducting safety assessments
One of the most important aspects of regulatory compliance is product safety. A CRO will conduct evaluations to assure the safety of your product. This can include assessing the toxicity of components, testing for allergies, and performing patch tests to detect potential skin reactions. This service can be especially helpful when testing a new formulation.
Providing expertise on global regulations
Skincare regulations differ by country, making it difficult for your brand to meet the various needs in each region. A CRO will assist by offering worldwide regulatory experience and ensuring that the your products are compliant in all regions where they're sold.
Conducting clinical trials
Clinical trials are an essential part of skincare product development and marketing. This research plays a significant factor in regulatory compliance. This is an area where we've seen the most recent regulation changes--the first updates in over 80 years.
A CRO will conduct clinical trials to gather data on the safety and efficacy of your product. This data can be used to support regulatory filings with the FDA and ensure that your products are compliant. Do you know what you're legally allowed to say about your product in your marketing? Clinical trials will provide you with data in order to make certain claims.
Providing guidance on Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP) are guidelines that ensure that products are consistently produced and controlled to the quality standards appropriate for their intended use. Compliance with GMP is a critical component of regulatory compliance. A CRO can help by providing guidance on GMP and ensuring that your products are manufactured in compliance with these guidelines.
Audits are a critical component of regulatory compliance in the skincare industry. A CRO can help by conducting audits of the brand's manufacturing facilities, suppliers, and other partners to ensure that they are compliant with regulations. This can include evaluating the quality control processes in place, ensuring that documentation is in order, and identifying any potential areas of risk.
Supporting regulatory filings
Regulatory filings are a required step in bringing your products to market. A CRO can assist with regulatory filings and ensure that your brand's products are in accordance with the regulations governing these filings. Data from clinical trials, safety assessments, and other studies may be provided to support regulatory applications.
Skincare regulatory compliance is easy with a CRO
Regulatory compliance is critical for skincare brands that want to bring safe and effective products to market. A CRO provides a range of services to ensure that your brand's products are compliant with FDA regulations. This can include staying up to date with changing policies, conducting safety assessments, providing expertise on global regulations, conducting clinical trials, providing guidance on GMP, conducting audits, and supporting regulatory filings.
By working with a CRO, your products will meet the highest standards of safety and efficacy.
Want to create your own clinical trial?
Citruslabs provides a simple and affordable way to prove that your products actually work. At Citruslabs, we design a clinical trial that is right for you and your budget, so you can start sharing research-backed product claims without spending a fortune. We offer the cohesive planning and management required to conduct successful clinical trials, from start to finish. Ready to get started? Let's talk! You can contact us here.