CLIENT FOCUS 

QUALITY

Biomedical Regulatory Institute was founded in 2001 by late Dr. Sandy Weinberg as a validation and regulatory consulting services organization. Today we provide a wide spectrum of expert services for our customers in the federal government, pharmaceutical, biotech, medical device, and laboratory instrument industries. Our engagements range from short-term projects to major regulatory undertakings.

For many companies, a strong alignment with a reputable remediation partner is often a vital first step toward restoring the confidence of regulatory agencies, shareholders, consumers, and other stakeholders. Biomedical Regulatory Institute's flexible, consultative model enables us to provide expertise, resources, and

Integrity, Client Focus and Quality are the values that form the Biomedical Regulatory Institute’s common base and are important components of our organization’s culture. These values permeate our way of working. Our goal is to maintain a leading position in these areas.

Our Mission Statement

Biomedical Regulatory Institute provides services that improve people’s quality of life, and that contribute to the commercial success of our customers in the life sciences field.

Biomedical Regulatory Institute's history as a compliance services organization gives us a unique competitive edge. Every solution we provide is built on a robust foundation of quality and intimate knowledge of the regulations governing pharmaceutical manufacture across the globe thereby enabling our clients to pursue commercial success while adhering to complex guidelines and requirements enforced by the regulatory authorities.

Each of our consultants has a ready access to the support of an extensive network of global staff of associated professionals and advisors. But what really sets Biomedical Regulatory Institute apart is our unwavering dedication on delivering superior service. We work tenaciously to establish the loyalty and trust of our valued customers. It's no wonder that many of them have worked with us for years.

At Biomedical Regulatory Institute, our culture, business practices, and strategic goals are defined by the organization's Mission Statement and our Core Values.

INTEGRITY 

Why Choose Biomedical Regulatory Institute?

comprehensive project management throughout any phase of a remediation engagement — either by augmenting staff or by planning and executing a major, multi-year project. We also perform quality systems implementation and risk reduction services, including audits, assessments, and mock FDA and regulatory agency inspections.

We strive to provide superior service and support in a consistent, cost-effective way. Our investments in training and continuous improvement in the quality of our services ensure that we maintain our reputation for excellence. From small projects to major long-term engagements, Biomedical Regulatory Institute stands behind every single solution we deliver — and our wide range of expertise enables us to serve as an end-to-end regulatory compliance provider to our valued clients.

Over more than a decade, we played a leadership role in guiding the implementation of regulatory compliance best practices throughout the life sciences industry. Our subject matter experts don't simply interpret the regulations; they actively contribute to their development and continuous refinement. Biomedical Regulatory Institute's trainers have conducted compliance seminars and workshops throughout the nation and around the world.

Integrity sets the standard for everything we do. Our policy is zero tolerance for unethical behavior. We strive to be honest, ethical, and fair in everything we do. We lead by example and concentrate on doing the right thing every time. We accept responsibility and hold ourselves and each other accountable.
 

We are focused on understanding our client’s needs and priorities. This focus helps us be responsive and innovative to best serve our customers. We build personal relationships and go above and beyond our client’s expectations.

 

Our goal is exceptional quality always. We strive to understand how our client defines success and align project quality criteria with client’s expectations. We are committed to perpetual improvement in everything we do.