Differences with European (EMA) and American (FDA) regulations

Regulatory Consulting for Herbal Products: EMA vs FDA Pathways

Navigating the regulatory landscape is a critical step in bringing herbal medicines to international markets. At Padideh Giah, we offer expert consulting services to help your herbal product meet the specific requirements of either the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA).

✅ Our Services Include:

• Strategic consulting to select the most suitable regulatory pathway (FDA or EMA)

• Preparation of scientific and traditional use dossiers

• Documentation support for Traditional Herbal Medicinal Products (THMP) under EMA guidelines

• Advisory for registering herbal products as Dietary Supplements under FDA regulations

• Market access planning for EU and U.S. herbal product launches

• Ongoing regulatory support and correspondence with relevant authorities

With our guidance, herbal startups and pharmaceutical companies can confidently enter global markets and ensure compliance with international standards.

• To receive consultation, please fill out the form below. Our experts will contact you as soon as possible.