Key Challenges
Challenges in Scaling Nutraceutical Products Across Borders
From inconsistent definitions to unpredictable claim approvals, nutraceutical brands face a fragmented regulatory reality that stalls innovation and delays market access.
Nutraceuticals
Bringing clarity, speed, and confidence to complex nutraceutical compliance.
Nutraceuticals
The nutraceutical industry blends health, wellness, and nutrition - offering preventive solutions through supplements, fortified foods, and functional ingredients. Consumer demand is soaring, driven by health awareness, aging populations, and personalized nutrition. With lighter regulatory pathways and rapid go-to-market cycles, success hinges on compliant claims, ingredient validation, and cross-market adaptation for labeling and classification.
$591
Billion Global Market
10,000+
New Products Launched Annually
7.5%
Global CAGR
No Universal Definition of ‘Nutraceutical’
Varying classifications (supplement, food, drug) create submission, labeling, and positioning challenges across markets.
Claims and Marketing Restrictions
Health and functional claims must be tailored per region - and backed by jurisdiction-specific scientific evidence.
Labelling and Packaging Disparities
Warnings, font sizes, country-specific disclaimers, and allergen declarations differ - even within trade regions.
Unstable Regulatory Environments
Emerging markets like ASEAN and GCC shift policies often, leaving brands exposed to unexpected compliance risks.
Lack of Harmonized Import and Notification Pathway
Some require full registration, others need only notification - and guidance is often outdated or unclear.
Halal, Vegan, and Cultural Sensitivity Layers
Cultural requirements - like Halal certification or disclosure of animal-derived ingredients - are now mission-critical for market access.
How Regnova Helps: Accelerating Global Access for Nutraceutical Brands
From classification to claims, Regnova helps nutraceutical innovators cut through fragmented regulations, validate product positioning, and scale compliantly across borders.
Product Classification and Category Mapping
Define best-fit classification (supplement or functional food) per region.
Claims Validation and Scientific Substantiation
Support for claims validation and substantiation as per country specific requirement. i.e DSHEA, FSSAI requirements, etc.
Labelling Compliance and Packaging Localization
Ensure font, language, allergen disclosure, and warnings align with local rules.
Ingredient Risk Assessment and Regulatory Review
Execute registration/notification and support customs-aligned labeling/import prep.
Registration, Notification, and Import Strategy
Manage certifications and disclosures to meet region specific requirements. i.e GCC, Malaysia, Indonesia, and EU standards.
Halal, Vegan, and Ethical Compliance Advisory
Manage certifications and disclosures to meet region specific requirements. i.e GCC, Malaysia, Indonesia, and EU standards.
Post-Approval Lifecycle Management
Handle renewals, variations, labeling changes, PV systems, and GMP compliance
Multi-Market Expansion Support
Accelerate synchronized launches across ASEAN, GCC, LATAM, and EU.
MAH and Local Agent Enablement
Act as your Marketing Authorization Holder or help appoint qualified in-country partners
Novel Ingredients notification
Listing of New Dietary Ingredient (NDI) if it is not listed in respective country FDA database.
That’s why we built RegNova
Your execution-first partner, bridging regulatory precision with innovation acceleration
Real Results. Global Impact.
From fast-track launches to seamless regulatory transitions, see how RegNova powers brands toward global expansion success.
The Future of Regulatory Submissions: AI Integration and Digital Transformation
General
20 Apr 2025
Regulatory submissions are going digital. Learn how AI, automation, and RegTech tools are reshaping compliance, reducing risk, and enabling faster market access across global regions.
Learn more
Saudi Arabia Nutraceutical Labeling: SFDA Regulations, Health Claims & Arabic Compliance
Nutraceuticals
20 Apr 2025
Discover how to navigate SFDA’s complex nutraceutical labeling requirements in Saudi Arabia. This whitepaper outlines claim restrictions, Arabic compliance rules, and a practical checklist to ensure your products meet market-entry standards.
Learn more
Navigated EU MDR’s Enhanced Requirements: A 2025 Compliance Guide
Medical Devices
20 Apr 2025
Explore what’s changed under MDR 2017/745 and how medical device manufacturers can stay compliant in 2025. From post-market surveillance to technical file readiness, this blog breaks down the essentials.
Learn more
Ready to Build Your Regulatory Advantage?
Let’s accelerate your compliant innovation, market entry success, and global expansion together.
