Regulatory Affairs Program

Global Herbal & Nutraceutical Focus

The global herbal and nutraceutical sector is expanding at an unprecedented pace, but with growth comes regulatory complexity. Products rooted in traditional knowledge are now expected to meet rigorous global standards of safety, quality, evidence, and transparency. The Regulatory Affairs (Global Herbal/Nutraceutical Focus) Program is designed to prepare students for this reality by blending regulatory science, AI-enabled workflows, and hands-on assignments that mirror real-world regulatory roles.

This Program is structured into four integrated learning pillars, each building practical and strategic regulatory expertise.

Literature & Hypothesis: Understanding Global Regulatory Pathways

The Program begins with a comprehensive exploration of the global regulatory landscape, covering Africa, the Middle East, the EU, the UK, and the US. Students learn that a single herbal or nutraceutical product may be classified very differently across regions as a medicine, dietary supplement, food supplement, or traditional-use product.

Interns study the roles of key authorities such as the U.S. Food and Drug Administration, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, and traditional medicine frameworks governed by bodies like AYUSH. Through literature reviews and regulatory mapping exercises, students compare approval routes, evidence expectations, and traditional-use registrations versus modern substantiation models.

The outcome of this phase is a regulatory hypothesis that identifies major global hurdles for herbal and nutraceutical approvals. Students support their conclusions with structured deliverables such as comparison tables, approval flowcharts, and concise analytical write-ups developing regulatory reasoning early in the program.

Scientific Prompting for Regulatory Dossiers

Moving from theory to documentation, interns are introduced to CTD and eCTD structures and the specific challenges botanical products face in quality and safety documentation. Unlike synthetic drugs, herbal products must address variability, marker compounds, sourcing, and historical safety data often with limited clinical evidence.

A unique feature of this module is training in AI-assisted scientific prompting. Students learn how to guide AI tools to draft regulatory-ready summaries, particularly Module 2 Quality and Safety overviews, using example products such as turmeric or neem. The focus is not automation alone, but accuracy, regulatory tone, and alignment with global expectations.

Deliverables from this phase include structured reports, presentation slides, and simplified educational content suitable for professional portfolios or social platforms, allowing students to showcase applied regulatory writing skills.

Product-Specific Regulatory Applications

In this phase, regulatory theory is applied directly to real product formats. Interns work through case studies involving herbal capsules, nutraceutical beverages, and AI-enabled diagnostic or wellness tools. Each product type introduces different compliance requirements across regions.

Students draft region-specific regulatory label content, addressing composition, dosage instructions, warnings, permitted claims, and mandatory disclaimers. They also analyze how regulatory positioning changes from one market to another highlighting the strategic role regulatory affairs plays in product development and branding.

The outputs include label drafts, comparative regulatory notes, and compliant social branding content, reinforcing the link between regulation, communication, and commercialization.

Strategy & Capstone Project

The final phase focuses on regulatory strategy and market entry planning. Interns explore fast-track approval options, nutraceutical-specific pathways, and emerging regulatory considerations for digital health and AI-based tools.

Students then develop a global regulatory dossier outline (Modules 1–5) and design tailored regulatory strategies for Africa, the EU, and the US. The capstone deliverable is a 3–5 page mini report that includes comparative regional strategies, regulatory risk assessments, practical recommendations, and a concise presentation summary.

This project simulates real-world regulatory consulting and in-house regulatory planning scenarios.

Outcome for Students

By completing this Program, students gain a strong understanding of global regulatory bodies and classification systems, hands-on experience with AI-assisted dossier drafting, practical knowledge of product-specific labeling and compliance, and the ability to design global regulatory strategies for herbal, nutraceutical, and digital health products.

Final Perspective

This Program is designed to move beyond academic learning. By integrating global regulations, AI-driven workflows, and real regulatory deliverables, it equips students with job-ready regulatory affairs expertise preparing them for international roles in compliance, regulatory strategy, and product development within the herbal and nutraceutical industry.

Dr Pravin Badhe
Founder and CEO of Swalife Biotech Pvt Ltd India/Ireland