When the world moves fast, compliance shouldn’t slow you down
Turning regulatory complexity into your competitive advantage — faster launches, smarter innovation, global growth.
Explore Our SolutionsOne Platform. Global Scale.
Regulatory Mastery.
Where complexity becomes your competitive edge.
Powerhouse for Regulatory and Innovation.
Regnova unifies domain expertise, AI-powered tech, and cross-industry insights into one seamless platform — built to accelerate growth.
Expanding borders with local precision.
With a strong presence across regulated and emerging markets, Regnova combines regional fluency with operational strength to execute across complex jurisdictions.
Navigating regulation with depth and foresight.
At the forefront of compliance, Regnova transforms evolving frameworks into actionable strategies — delivering approvals, launches, and lasting market success.
Explore the Solutions
Powering Global Market Success
Market Entry Acceleration Program
From product classification to registration, this program helps brands cut through regulatory delays and enter new markets faster — with clarity, compliance, and commercial readiness
Innovation Acceleration Program
This program supports early-stage innovation with category feasibility, risk mapping, and claims validation — helping you move smarter from concept to commercialization, without regulatory surprises.
Manufacturing Compliance & Launch Support
From strategic CDMO sourcing to GMP qualification and site audits, we help ensure your manufacturing partners meet regulatory expectations and launch timeline — minimising risk and unlocking commercial speed.
Regulatory Lifecycle Management
Streamline your product’s regulatory journey from development to post-market compliance. Our end-to-end Regulatory Lifecycle Management ensures global alignment, faster approvals, and risk mitigation.
Regulatory Execution Services
Whether you're entering new markets or managing global approvals, our regulatory experts handle everything from dossier prep and submission to post-approval management — built to deliver at pace, without shortcuts.
Innovation Enablement Support
Our team works closely with yours to guide new product ideas through feasibility checks, claims assessments, and reformulation strategies — ensuring innovation is aligned with compliance from day one.
Commercialization Support Services
From GMP compliance to claims positioning and documentation adaptation, we ensure your product is prepared for commercial success across target markets — with no late-stage surprises.
Aggregated CMO/CDMO Partner Network
Our curated network of contract manufacturers and development partners is vetted for quality, compliance, and speed — helping you scale faster without compromising regulatory integrity.
Specialist Partner Ecosystem
We’ve built a global ecosystem with regional agents, clinical partners, and innovation collaborators — enabling integrated execution, faster approvals, and smooth market entry in complex regions.
Platform-Enabled Regulatory Intelligence
RegNova One combines automation, real-time monitoring, and AI-driven insights — helping your team anticipate changes, reduce manual errors, and drive faster, more confident regulatory decisions.
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Global Execution Hubs
Our global execution hubs handle end-to-end execution — from regulatory communications and HA engagement to localization and market-specific planning — ensuring global consistency with local precision.
Expertise Across Growth Industries
From innovative health brands to specialized pharmaceutical launches, RegNova powers regulatory success across diverse, fast-evolving sectors.
Pharmaceuticals (Rx and OTC)
When it comes to pharma, there's no room for error. We manage everything from product classification to submission pathways, variation handling, and HA engagement — especially in high-growth, high-regulation regions. Whether it is Rx or OTC, we help you stay compliant and competitive.
Health & Wellness
The wellness space moves fast — and regulation often struggles to keep up. When you’re launching a novel format, we bring regulatory clarity and structured foresight to help you move quickly, stay compliant, and scale with confidence.
Medical Devices
Navigating the complex landscape of medical device regulations requires expert guidance. We help you bring your medical device to market efficiently. From regulatory strategy and device classification to FDA submissions, CE marking under EU MDR, ISO 13485 QMS support, and post-market surveillance.
Nutraceuticals
Bringing nutraceutical products to market requires a clear understanding of evolving global regulations. We help you in achieving full compliance with labelling, safety, claims substantiation, and product registration requirements for supplements.
Beauty & Personal Care
Ensure your beauty and personal care products meet global regulatory standards with ease. We offer expert support in ingredient compliance, label review, claims substantiation, safety assessments, and product registration across the globe.
Functional Foods and Beverages
Navigating food regulations is essential for market access and consumer trust. Our expert team supports food businesses with regulatory compliance services including ingredient and formulation review, nutritional labelling, health claims validation, food safety standards, and international product registration.
Why RegNova is Your Execution-First Growth Partner
Regulatory expertise alone is not enough. Execution excellence, innovation foresight, and platform-driven precision set RegNova apart.
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Platform-Powered Compliance
Real-time regulatory intelligence through RegNova One.
Innovation-Aligned Thinking
Regulatory foresight embedded in product development.
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Global Market Readiness
Multi-market expertise across Asia, Middle East, Emerging Markets.
Global Presence. Network Driven. Seamless Delivery.
Proven success stories
What stood out with RegNova was the people — sharp, proactive, and genuinely invested in our success. We had a huge pipeline of complex formulation and navigating compliance in multiple markets was so challenging but with this team working with us at every step made it an experience to remember.
Baraa Rahmy
With a business our size and multiple asian markets, we needed a program that could handle complexity without slowing us down. RegNova delivered just that. The biggest advantage I felt was the ease of working with one team and getting multi-market expertise.
Krishna Jayaraman
Expanding into the GCC felt like a big leap for us, but RegNova made it easy. Things like verification of our Australian halal certification with Dubai municipality to working with MOH for Ashwagandha Gummies - the team showcased great knowledge and expertise. With regular follow-ups and effort we were able to launch quicker than planned.
Yaser Siddiqui
We had been looking for a regulatory partner for our India expansion and kept getting conflicting guidelines and information from multiple agencies — but RegNova brought clarity from day one. They asked the right questions, flagged risks we hadn’t thought of, and kept things moving smoothly. It never felt transactional — they cared about getting it right.
Mili Kale
Launch right with Regnova
From compliance to commercial success — we’ve got you covered.
Real Results. Global Impact.
From fast-track launches to seamless regulatory transitions, see how RegNova powers brands toward global expansion success.
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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.
Navigated EU MDR’s Enhanced Requirements: A 2025 Compliance Guide
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.
Ready to Build Your Regulatory Advantage?
Let’s accelerate your compliant innovation, market entry success, and global expansion together.
