Regulatory Affairs (Global Herbal/Nutraceutical Focus)

This internship introduces students to the global regulatory landscape for herbal and nutraceutical products, integrating AI tools and practical assignments to build career-ready regulatory skills. It spans four sections, each focusing on a key aspect of regulatory affairs.

Literature & Hypothesis (Global Pathways)
Students explore regulatory bodies across Africa, the Middle East, EU, UK, and US, learning how herbal/nutraceutical products are classified differently (medicine vs supplement vs traditional use). Assignments include mapping regulatory bodies, comparing classifications, and analyzing approval pathways. The outcome is a hypothesis on regulatory hurdles with deliverables like tables, flowcharts, and short write-ups.

Scientific Prompting for Dossiers
Interns are introduced to CTD/eCTD structures and the unique challenges herbal products face in quality and safety documentation. They practice AI prompting to draft Module 2 summaries (Quality & Safety) for herbal products such as turmeric or neem. Outputs include reports, slides, and social media drafts to showcase learning.

Product-Specific Regulatory Applications
Through case studies, interns study regulatory applications for herbal capsules, nutraceutical drinks, and AI diagnostic tools. They draft regulatory label texts tailored to regional rules, including product composition, dosage, warnings, claims, and disclaimers. Deliverables include label drafts, comparative notes, and social branding content.

Strategy & Project Submission
The final section focuses on fast-track approvals, nutraceutical pathways, and digital health/AI regulations. Students prepare a global regulatory dossier outline (Modules 1–5) and develop strategies for Africa, EU, and US markets. The capstone project is a mini report (3–5 pages) with comparative strategies, recommendations, and presentations.

• Outcome for Students
  By completing this internship, students will:

• Gain knowledge of regulatory bodies and classification systems worldwide.

• Learn AI-assisted dossier drafting.

• Understand product-specific labeling and compliance.

• Build global regulatory strategies for herbal, nutraceutical, and digital health products.

• The program equips students with practical regulatory affairs expertise, preparing them for global roles in compliance, product development, and strategy.