About Us

Our Expertise

The Weinberg Group is the global leader in regulatory and compliance services, with headquarters in Washington, D.C. For over 33 years, we have provided biotech, medical device and pharmaceutical consulting services to companies of every size on every continent, supplying them with viable and efficient drug development pathways and compliance solutions.

Our experienced team of FDA consultants and FDA compliance consultants work with you to develop regulatory strategies and submissions; and remediate, maintain and improve regulatory compliance. Though much of our work is project-based, for some clients, we assume all regulatory responsibilities for a fixed monthly fee as a part of our Outsourced Regulatory Affairs (ORA) program.

The Weinberg Group’s pharmaceutical consultants understand the value of your new product pipeline and work with you to develop regulatory strategies that optimize likelihood of approval, minimize cost and increase speed to market. In many cases, we execute the strategy we design, providing literature research, preparing for and attending key FDA meetings, and developing regulatory submissions. Our depth of experience and knowledge of global and FDA regulatory affairs has helped us achieve a smooth and professional relationship with virtually every division in FDA and has paved the way for cooperation with EMA in reaching agreements on complex issues. Many of our services are also available for companies seeking to market their product internationally.

The seasoned FDA compliance consultants who make up our compliance practice each have at least 10 years’ experience in quality assurance (QA) auditing. Whether you need a GCP, GMP, GLP, PV audit, or a mock FDA inspection, we can help. Our auditors are strategically located throughout the world, giving us the capabilities to effectively and efficiently meet the challenges of our clients’ global auditing needs.

Over the years we have developed a simple approach to our work that guides each of our projects: the essence of successful drug development is the management of risk and the removal of uncertainties. We are driven to create successful regulatory outcomes that benefit the client and society – on time and within budget.