WE ARE REGULATORY FACTOR

ABOUT US

Trusted Regulatory Compliance Experts with 30+ Years of Industry Experience

 

With more than three decades of expertise, we specialize in helping organizations navigate complex regulatory landscapes with confidence. Our deep industry knowledge, combined with customized strategies, empowers you to meet compliance requirements efficiently and effectively.

 

We have successfully guided companies across a wide range of industries through local, national, and international regulatory challenges. Whether you’re entering new markets or enhancing existing compliance frameworks, our proven track record helps reduce risk, speed up approvals, and maintain operational integrity.

 

What sets us apart is our unwavering commitment to excellence and our ability to deliver nuanced, business-focused solutions. As your trusted partner, we develop strategies that not only meet regulatory demands but also safeguard your reputation and support sustainable growth.

WHY CHOOSE US?

REGULATORY STRATEGY & PLANNING

Our Regulatory Roadmaps provide a structured step-by-step plan to guide your product through the necessary compliance checkpoints. Whether you’re launching a new product or modifying an existing one, we ensure every regulatory detail is mapped out clearly to avoid delays and reduce cost.

GLOBAL MARKET ACCESS SOLUTIONS

Global Market Access (GMA) is the key to legally selling and distributing your product across international borders. It involves navigating country-specific regulations, securing certifications, and ensuring full compliance with local standards and legal requirements

TECHNICAL DOCUMENTATION & COMPLIANCE FILE MANAGEMENT

Maintaining up-to-date technical documentation and regulatory compliance files isn’t just about ticking boxes—it’s your shield against costly delays, rejected submissions, or failed audits.

EU MARKET SOLUTIONS

From CE Marking to RoHS and RED compliance, we help you understand and fulfill all applicable directives and standards—minimizing delays, avoiding costly mistakes, and positioning your product for success across EU member states.

TESTING & CERTIFICATION SUPPORT

Regulatory testing and certification requirements are constantly evolving—and getting it wrong can cost you time, money, and market access. We guide you through every step of the testing and certification journey, ensuring your products meet technical, safety, and wireless compliance standards globally.

REGULATORY ENGAGEMENT & REPRESENTATION

Navigating international compliance often means interacting directly with regulators, notified bodies, and certification authorities. We act as your trusted representative, ensuring your product—and your business—is positioned for success in every target market.

Regulatory Factor

Ensure your organization is always compliant with the latest regulations. Partner with us for expert regulatory compliance services that streamline your processes and safeguard your business. Contact us today to learn more about how we can help you achieve your regulatory compliance goals.

CONTACT US

OUR CLIENTS FEEDBACK

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Working with Regulatory Factor was a turning point for our product rollout. They didn’t just provide technical expertise—they communicated in a way that made sense to our whole team, even those with no compliance background. They mapped out the entire approval process, identified the most efficient path to meet all requirements, and guided us every step of the way. The result was a successful launch without the stress or uncertainty we had experienced in the past.

Sean
Ceo

As a small company entering international markets for the first time, we were overwhelmed by the complexity of regulatory requirements. Regulatory Factor not only guided us through the process but also educated our team so we could make informed decisions. They handled all the details—from documentation to dealing with regulatory bodies—allowing us to focus on product development. Their dedication and knowledge turned a stressful challenge into a successful achievement

Jack
Director Product Development

The team at Regulatory Factor truly went above and beyond. They identified compliance gaps in our early designs, helped us address them efficiently, and prevented costly re-certifications later. Their proactive planning saved us months of potential delays. We’ve worked with other consultants before, but none have matched Regulatory Factor’s combination of technical skill, responsiveness, and genuine commitment to our success.

Susan
Engineering Manager

From CE Marking to navigating tricky country-specific approvals, Regulatory Factor handled every requirement with precision and professionalism. Their team anticipated challenges before they happened and worked behind the scenes to keep everything moving forward. What could have been a frustrating, time-consuming process turned into a smooth, well-managed journey to market. We simply couldn’t have done it without them.

Robert
Regulatory Affairs Manager

The depth of regulatory knowledge at Regulatory Factor is unmatched. Their consultants quickly identified potential compliance risks we hadn’t even considered—issues that could have delayed our launch and cost us significantly. By addressing these risks early, they saved us valuable time, avoided expensive rework, and gave us complete confidence moving forward. They’re not just a service provider—they’re a true strategic partner.

Conrad
VP of Product Development

Regulatory Factor took the stress out of global compliance for our company. From the very first call, their team made a complicated process feel clear and achievable. They walked us through every step, from understanding which standards applied to our products, to creating a structured plan that kept our project on track. Thanks to their expertise and attention to detail, we met our deadlines without last-minute scrambling and launched in record time.

Maria
Operations Director

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