rEGULATORY SERVICES
Explore our unmatched regulatory expertise covering an extensive array of industries, including foods, cosmetics, drugs, psychedelics, cannabis, pet products, supplements, and natural health products.
With in-depth knowledge of key government acts and regulations in both the US and Canada, such as the Food and Drug Administration (FDA) regulations, Health Canada regulations, and the Cannabis Act, we ensure compliance at every turn.
REGULATORY AFFAIRS
Whether you need assistance with licensing, quality assurance (QA), Standard Operating Procedures (SOPs), compliance activities, audits, or site qualification for manufacturing facilities, our comprehensive solutions have you covered.
Trust us to navigate the complex regulatory landscape seamlessly, guaranteeing that your products meet and exceed regulatory requirements with confidence.
services for natural health products in canada
At Salix Sciences, we specialize in providing comprehensive services to help you navigate the complex regulatory landscape of natural health product approval in Canada. Obtaining a Natural Product Number (NPN) from Health Canada is crucial for marketing your product legally and ensuring consumer trust. Our dedicated team of experts offers a full suite of services to support you through every step of the approval process.
regulatory consulting
Our seasoned regulatory consultants provide strategic advice tailored to your product’s specific needs. We conduct a thorough assessment of your natural health product to determine the best regulatory pathway to ensure all compliance requirements are met.
PRODUCT FORMULATION REVIEW
We review your product formulation to ensure it adheres to Health Canada’s stringent guidelines. Our experts analyze the ingredients, dosages, and combinations to guarantee your product is safe, effective, and compliant with regulatory standards.
DOCUMENTATION AND SUBMISSION PREPARATION
Navigating the documentation process can be daunting. Our team prepares and compiles all necessary documentation, including:
Product License Application (PLA)
We complete the comprehensive PLA form, detailing your product’s ingredients, dosage form, recommended use, and more.
Safety and Efficacy Evidence
We gather and organize clinical studies, scientific literature, and traditional use information to substantiate your product’s safety and efficacy.
Quality Assurance Documentation
We ensure your product meets Good Manufacturing Practices (GMP) by preparing documentation that demonstrates your manufacturing processes are up to standard.
Labelling compliance:
Proper labeling is essential for NPN approval. We assist in developing compliant labels that meet Health Canada’s requirements, including accurate ingredient listing, health claims, and bilingual labeling (English and French).
SUBMISSION AND FOLLOW UP
Once all documentation is prepared, we submit your application to Health Canada on your behalf. Our team maintains ongoing communication with regulatory authorities, addressing any inquiries or requests for additional information promptly to expedite the approval process.
POST MARKET SURVAILANCE
After your product receives NPN approval, we offer post-market surveillance services to ensure continued compliance. We monitor adverse reactions, update labeling as needed, and provide ongoing support to address any regulatory changes or issues.
WHY CHOOSE SALIX SCIENCES?
Expertise
Our team has extensive experience in the natural health product industry and deep understanding of Health Canada’s regulatory framework.
Personalized Service
We tailor our services to meet your unique needs, ensuring a smooth and efficient approval process.
Commitment to Quality
We are dedicated to maintaining the highest standards of quality and compliance, helping you bring safe and effective natural health products to market.
Partner with Salix Sciences to streamline your natural health product approval process and achieve NPN approval with confidence. Contact us today to learn more about how we can support your journey to success in the Canadian market.