Herbal Regulatory Compliance

Herbal Regulatory Compliance

Our scientific and therapeutic knowledge of herbal products creates clear and effective regulatory guideline reports designed for your business.

Herbal product evaluations

The regulatory route for herbal products and botanicals depends on formulation, product claims and sometimes client preference. We identify the appropriate category for each product, such as food supplements, medicines, medical devices or traditional herbal medicinal products. We can assess your product for Traditional Herbal Registration (THR) Certification, and tell you if it is considered a ‘borderline’ product.

Company compliance and sourcing services

Avena Consultants advise on licenses and authorisations required from national regulators. We provide Good Manufacturing Practice (GMP) guidance, and sourcing of Qualified Persons (QPs) and testing laboratories.

Formulation projects

Concept to commercialisation, providing data on herbal formulations to suit your preferred regulatory route, and sourcing the complement of services thereafter.

Traditional Herbal Registration (THR) dossiers

We compile the full dossier or individual modules providing guidance on data requirements and gathering scientific and traditional data for you.

THR/THMPD dossiers comprise 5 modules:

  1. Administration, company and product info
  2. Common Technical Document (CTD), summaries on all the other modules
  3. Quality requires GMP and full raw material to finished product data.
  4. Safety, research on adverse events, dosage, side effects etc.
  5. Traditional Use evidence of market use for given indication for same or very similar formulation.

Successful applications must satisfy the regulators that the herbal product is safe, of good quality and has been used traditionally for 30 years.