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
Fast-track regulatory approvals and launch with confidence across Asia, the Middle East, and emerging markets.
Innovation Commercialisation
Embed compliance into your innovation journey for smarter, faster product launches.
Post Market Surveillance
Sustain market access post-launch with seamless renewals, vigilance, and compliance updates.
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.
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.
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.
Expertise Across Growth Industries
From innovative health brands to specialized pharmaceutical launches, RegNova powers regulatory success across diverse, fast-evolving sectors.
Pharmaceuticals
End-to-end support across Rx and OTC segments — from dossier preparation and submission strategy to lifecycle management. Designed for compliant, efficient launches in Asia, GCC, EU, and emerging markets.
Veterinary
Regulatory strategy and execution for companion and livestock health products. Covers classification, claims, and documentation across diverse regulatory frameworks to ensure market readiness and compliance.
Medical Devices
Comprehensive regulatory execution for medical devices, including classification, technical file preparation, CE/FDA readiness, and post-market surveillance. Ensures audit-ready submissions and accelerated approvals across global markets.
Nutraceuticals & Health Supplements
Focused regulatory pathways for health supplements and functional ingredients. Includes claims validation, ingredient risk analysis, and labeling compliance to unlock rapid approvals and cross-border market expansion.
Personal & Beauty Care
Regulatory-compliant innovation across skincare, cosmetics, and personal wellness categories. Covers labeling, claims substantiation, ingredient safety, and multi-market registration to enable faster, globally aligned product launches.
Herbal & Traditional Products
Tailored regulatory execution for Ayurveda, TCM, and botanical products. Supports claims substantiation, safety validation, and multi-market registration for compliant global launches in traditional medicine formats.
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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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.
