Headquartered in Washington DC, The Weinberg Group helps its clients develop and implement regulatory strategies designed to achieve rapid and efficient FDA approvals. For each of the strategic paths defined in any given strategy, we provide the estimated cost, milestones, timing and probability of success. Many of our clients request our help in executing the strategy we provide. In doing so, our experienced consultants are commonly asked to accomplish a wide range of tasks from developing an FDA briefing package to developing a complete submission.

As a trusted partner, The Weinberg Group provides support through the regulatory product development milestones for pharma, biotech and devices shown below. For some clients, we act as a regulatory department, providing all aspects of regulatory strategy execution and for others we assist with just one aspect, e.g. preparing a pre-IND briefing package. Regardless of scope, our consultants are prepared to help you and will see your project through to completion.