Herbal Medicines

Herbal medicines have been used for centuries and continue to play a vital role in modern healthcare, offering natural solutions for prevention and treatment of minor conditions. However, the path to market for herbal medicines is complex, with diverse regulatory frameworks requiring scientific rigor, precise documentation, and compliance with national standards. At Nutra Compliance, we provide expert guidance to ensure your herbal medicines meet all regulatory requirements, helping you deliver trusted and high-quality products to the global market.

Your Partner in Herbal Medicines Compliance

Whether your product is a traditional herbal remedy, a herbal medicinal product, or a dietary supplement with botanical ingredients, our team of regulatory experts is here to simplify the approval process. With a deep understanding of global regulations, scientific expertise, and decades of experience, we enable you to navigate the complexities of compliance with confidence.

Our Services

Regulatory Classification and Strategy

Herbal products can fall under multiple regulatory categories, from traditional herbal medicines (THMs) to over-the-counter remedies based on well-established use or food supplements. We help you classify your products correctly, ensuring they meet specific regional requirements such as the EU Traditional Herbal Medicinal Products Directive (2004/24/EC) or equivalent regulations in the UK.

Dossier Preparation and Submissions

Herbal medicines require robust documentation, including evidence of traditional use, safety data, and sometimes efficacy studies. We prepare and submit comprehensive dossiers that meet regulatory requirements (eCTD), facilitating smooth approvals from national agencies in Germany and the UK.

Ingredient and Quality Assessments

Ensuring the safety and quality of botanical ingredients is paramount. We conduct thorough assessments of your raw materials, including active compounds, , ensuring compliance with pharmacopeial standards and other quality benchmarks.

GMP and Manufacturing Compliance

Herbal medicines are subject to Good Manufacturing Practice (GMP) requirements to ensure product quality and safety. We provide guidance on implementing GMP-compliant processes and conducting audits to meet regulatory standards.

Labelling and Claims Substantiation

Regulatory compliance extends to product labelling and claims. We ensure your labels accurately reflect your product’s purpose, usage, and benefits while adhering to legal frameworks before submitting them to the authorities for approval.

Market Access and Global Support

With local expertise in Germany and the UK, we facilitate market entry for your herbal medicines, managing registrations, certifications, and liaising with regulatory authorities to ensure Marketing Authorisations are obtained. Our global network of experts can support similar frameworks in over 90 countries.

Post-Market Surveillance and Compliance

Herbal medicines require ongoing compliance even after market entry. We assist with post-market surveillance, pharmacovigilance, and regulatory updates to maintain the safety and integrity of your products.

Empowering Your Herbal Innovations

Herbal medicines bridge the gap between tradition and modern healthcare, offering natural solutions to global health challenges. At Nutra Compliance, we’re passionate about helping you bring these products to market. With our guidance, you can focus on innovation and patient care, knowing that every regulatory detail is expertly managed.

Take the First Step with Nutra Compliance

Contact us today to learn how our regulatory services for herbal medicines can support your success. Together, we’ll navigate the complexities of compliance, ensuring your products reach the market safely, efficiently, and effectively.