Food for Special Medical Purposes (FSMP)
Food for Special Medical Purposes (FSMP) plays a critical role in managing the nutritional needs of individuals with specific medical conditions. These highly specialised products must meet stringent regulatory standards to ensure safety, efficacy, and compliance. At Nutra Compliance, we provide expert guidance to help you navigate the complexities of FSMP regulations, ensuring your products meet the highest standards and reach the patients who need them most.
Your Partner in FSMP Compliance
From development to market access and post-market monitoring, our FSMP regulatory services are designed to simplify the approval process while upholding the integrity and quality of your products. With our extensive expertise in nutrition science, toxicology, and global regulations, we empower you to focus on delivering innovative solutions for patient care.
Our Services
Regulatory Classification and Strategy
Determining whether your product qualifies as an FSMP is a critical first step. We provide expert assessments to confirm FSMP classification under relevant frameworks, such as EU Regulation (EU) 2016/128, Codex Alimentarius, and FDA guidelines (as Medical Food).
Formulation and Compliance Reviews
We assess your formulations to ensure they meet regulatory requirements for FSMPs, including appropriate nutrient levels, intended use claims, and compliance with medical necessity standards.
Dossier Preparation and Scientific Evidence
FSMPs require robust documentation to demonstrate safety, efficacy, and compliance. We compile detailed product dossiers, including your clinical evidence, nutritional composition, and risk assessments, ensuring successful submissions to regulatory authorities.
Labelling and Claims Validation
FSMP labelling demands precision to communicate intended use, nutritional composition, and medical guidance. We ensure your labels and claims comply with legal requirements while clearly addressing the needs of healthcare professionals and patients.
Market Entry and Regulatory Support
With expertise in over 90 countries, we guide your FSMPs through regulatory approval processes worldwide, managing applications, liaising with authorities, and facilitating swift market entry, including available national reimbursement schemes.
Post-Market Surveillance
Once your FSMPs are on the market, we can provide ongoing compliance support, monitoring safety, addressing regulatory updates, and managing product modifications to ensure continued adherence to legal requirements.
Why Choose Nutra Compliance?
- Specialised Expertise: Our multidisciplinary team combines regulatory know-how with deep scientific understanding to address the unique challenges of FSMPs.
- Global Reach: We’ve supported FSMP products across diverse regions, ensuring compliance with local regulations and inclusion on reimbursement schemes.
- Tailored Solutions: Each FSMP product serves a unique medical purpose, and our strategies reflect this individuality to meet your specific needs.
- Commitment to Quality: We uphold the highest standards of safety and compliance, helping you deliver trusted products that improve patient outcomes.
Elevating Patient Care Through Compliance
FSMPs are more than just products—they’re lifelines for individuals managing complex medical conditions. At Nutra Compliance, we’re committed to helping you bring these vital products to market with confidence and compliance. By partnering with us, you can focus on innovation and patient care, knowing that every regulatory detail is expertly managed.
Let’s Collaborate
Contact Nutra Compliance today to learn how our FSMP regulatory services can support your goals. Together, we’ll navigate the complexities of compliance to ensure your products reach the patients who rely on them.