Bridging tradition and regulation to accelerate global access for herbal and natural health products.
Rooted in centuries of use, herbal and traditional medicine is now a commercial powerhouse blending cultural heritage with modern compliance. Products span Ayurveda, TCM, and botanical extracts - serving both mainstream wellness and therapeutic needs. Global expansion requires cross-market substantiation, labeling alignment, and safety documentation to navigate divergent classification and approval regimes.
Where Traditional Knowledge Meets Modern Regulatory Barriers
Herbal, Ayurvedic, and traditional medicine brands face rising regulatory scrutiny - from product classification to cross-market substantiation - limiting their ability to scale globally.
Ayurveda, TCM, Unani, Kampo, or Siddha products are classified differently across markets - leading to complexity in registration and claims.
No global pathway exists - each region demands localized documentation, licenses, and regulatory navigation.
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Historical use doesn’t always meet scientific evidence standards - limiting marketing and health claims internationally.
Heavy metal, microbial, and pesticide residue tests are mandatory in many markets - often requiring batch-level testing and third-party COAs.
Local naming conventions, Arabic, Thai, Bahasa or Latin translations, and culturally adapted labels are mandatory in many markets.
Markets like UAE, Indonesia, and Malaysia are rapidly evolving - often tightening traditional product regulations toward mainstream pharmaceutical standards.
From Ayurvedic and TCM classification to cross-market claim substantiation, Regnova helps herbal and traditional brands meet modern regulatory standards - without losing their identity.
We assess your formulation and determine the most feasible regulatory path in each target market (e.g., dietary supplement, TCM, traditional herbal medicine, NHP, or health supplement)
We review your technical files and identify gaps based on local regulations (e.g., FDA 21 CFR, EU Regulation 1924/2006, AYUSH standards, etc.)
Preparation of CTD/eCTD dossiers for THMPs, FSMPs, and TCM products
We help you craft compliant marketing claims and ensure your labels meet the language, font size, warning, and ingredient disclosure requirements in each country.
Act as your Marketing Authorization Holder or help appoint qualified in-country partners
We offer lifecycle regulatory services including periodic renewals, safety monitoring, batch release, and recall preparedness.
Advise on reformulation strategies to meet regulatory limits (e.g., restricted herbs, heavy metals) Optimize for ingredient compliance, bioavailability, or cost efficiency Recommend globally accepted excipients and processing aids
Handle renewals, variations, labeling changes, PV systems, and GMP compliance
Support generation of traditional use evidence (20–30 years documentation where needed) Collaborate with CROs to design bridging or observational studies Prepare bibliographic evidence for EU/Canada/NHP applications
Your execution-first partner, bridging regulatory precision with innovation acceleration
From fast-track launches to seamless regulatory transitions, see how RegNova powers brands toward global expansion success.
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Let’s accelerate your compliant innovation, market entry success, and global expansion together.
