About Us

Mission

Our mission is to develop optimal regulatory strategies, achieving shorter approval times and greater marketing potential for our clients and their products.
We strive to generate and sustain the growth of our client companies by growing their regulatory and business potential.
We’re committed to growing our business by embracing best practices and the latest knowledge, developing solid partnerships, and delivering client satisfaction.

Core Values

Professionalism & reliability
We approach the business as professionally as possible. We build mutual trust and strive to be a highly trusted partner. Building personal and professional integrity is of great importance to us. We want our partners to know that they have responsible professionals they can always rely on.

Welfare & security

We do not make any compromises regarding welfare and safety. Client and end-user satisfaction is our top priority, together with customer (CX) and user experience (UX). We believe that quality is fundamental to creating and delivering high added value. That is why we strictly follow all relevant regulations and standards.

Value & contribution

We want to work meaningfully and purposefully. We contribute and create value – for customers, users, employees, partners and the community. The satisfaction of others gives us the driving force to move on.

Why Choose Us

You have invested time, money, and energy into developing your product. We believe that our professional service and commercially-oriented regulatory support are vital to the success of your business.
BioReg provides a service with an excellent price-quality ratio – a highly specialized service at an affordable price. This competitive advantage is possible due to our solid and distinctive competencies accumulated over the years.
BioReg’s strategic advantage is its ability to identify easy and often innovative solutions within the regulatory milieu. We examine all the potential regulatory avenues available to a client to determine and develop the most beneficial product strategies in each case.
Extensive professional knowledge, rich hands-on experience, methodological approach, and scientific insight enable BioReg to develop optimal regulatory strategies, achieving shorter approval times and more significant marketing potential for our clients and their products.

Our principles

Our work is based on six principles. Following these principles allows us to improve our performance and deliver high-value solutions constantly. Our business principles are derived from our value statements – mission, vision, and core values.

Principle 1: Focus on the client’s needs
The client’s needs always come first.
Principle 2: Dedicated & professional approach
We love our work, and we do it passionately. We are genuinely committed to client satisfaction.
Principle 3: Outcome orientation & focus on results
With us, results always come before hierarchy and procedures. We are outcome-oriented and consistently deliver concretely visible results to our clients.
Principle 4: Transparency & collaboration
We work honestly, transparently, and collaboratively. If we have a problem, we don’t ignore it. If we have information, we share it. Together we can do better.
Principle 5: Flexibility & sustainability
Clients’ needs and current circumstances always guide our work. Therefore, our focus is on sustainability, not on quick results.
Principle 6: Delivering superior value
The essential principle of our work is – to create and deliver superior value at an affordable price. We achieve this by putting the client’s needs first and striving for sustainable and measurable results.

Our Vision

Our vision is to be a cutting-edge, reliable regulatory consultancy for medical devices and other healthcare products. We aspire to become a leading boutique regulatory consultancy in Israel and a regulatory provider of choice in the EU and the U.S.
We strive to create an ecosystem of experienced service providers that can support all development, regulatory, and quality activities throughout the product lifetime. In this way, we help clients to bring safe products to the market cost-effectively, making benefit to all stakeholders and the broader community.

Passion & commitment

We love what we do. We like challenges because they help us develop together with our clients. We are optimists and believe in success. Our passion is to turn knowledge and experience into results.

Learning & growth

We are constantly learning and improving ourselves. We always try to be in-line with the current regulations and standards, to keep up to date and to acquire new knowledge and skills. We strive to grow and develop, not only in terms of size, but also in terms of enhanced competencies and personal development.

Our approach

We tackle complex regulatory challenges using a six-phase approach. This method allows us to understand the client’s needs fully, perform the work professionally, and deliver high-value-added results to the client. We listen, understand, design, execute and follow up.
Phase 1: Get to know each other
We introduce ourselves and get to know you. We establish productive communication and strive to build a solid foothold for cooperation from the beginning.
Phase 2: Identify needs & objectives
We listen carefully to understand your needs and objectives. The agreement on project goals builds a strong starting point.
Phase 3: Prepare your plan
We create the working plan with committed deadlines, milestones, deliverables, and detailed reporting responsibilities. Then, we define the best possible strategy and create a roadmap for its implementation.
Phase 4: Implement planned activities
We collect and analyze data, write plans, protocols and reports, build quality systems, identify testing labs, communicate with authorities, submit product regulatory applications and perform post-market activities. In short, we implement whatever we agreed previously.
Phase 5: Evaluate results & stay on track
The implementation is continuously coupled with evaluation in an iterative manner. We ask for feedback to improve ourselves.
Phase 6: Maintain & improve relationships
Our approach is relational, not transactional. Our clients are our partners, not customers. We like new projects, but more than that, we cherish long-term relationships. We are dedicated to your growth.