The Weinberg Group is the global leader in regulatory and compliance
services, with headquarters in Washington, D.C. For over 35 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 the 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.