The Weinberg Group

For the past 28 years, The Weinberg Group has assisted pharma, biotech and device clients in the development and implementation of successful and innovative regulatory strategies. In addition, we have worked with hundreds of companies to remediate, maintain and improve their regulatory compliance.

What makes us different? We are experienced, privately held and totally independent. Our project managers and consultants understand your business objectives and commit to achieving them with you.

Product Development

“What is the optimal regulatory strategy for my new small molecule? Can I use the 505(b)(2) pathway?”

“I have a pre-IND meeting coming up. Can you help us prepare the briefing package?”

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Compliance

“I need 100 GCP audits conducted across the world in the next six months. Can you get this done?”

“I just received an FDA Warning Letter regarding deficiencies at one of my manufacturing plants. How should I respond?”

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Due Diligence

“My company is considering the acquisition of a new device. How can I estimate the regulatory/compliance risk associated with this acquisition?”

“We just acquired a new company. Can you provide a regulatory/ compliance assessment of its practices?”

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Webinar Replay: “FDA User Fees – What Have They Done For You Lately?”

A Webinar Presented by The Weinberg Group April 25, 2012 FDA user fees have been fact of life for regulated industry for nearly two decades. As you continue to comply by paying the fees, you should understand what the revenue does for you. This webinar will provide a history of the Prescription Drug User Fee Act (PDUFA) from its

CEO Matthew Weinberg Presents at FDA Clinical Trials Hearing

April 23 - The Weinberg Group CEO, Matthew Weinberg, presented today at FDA’s hearing titled “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice.” Mr. Weinberg presented on the mandatory need for audits and audit independence. A full copy of his presentation can be found here.

The Weinberg Group to Sponsor and Participate in Linking Leaders Roundtable Series

Linking Leaders’ Clinical Quality roundtable series provides pharmaceutical and biotech executives a forum to share insights and experiences, benchmark progress, and collaborate on solutions with like-minded peers facing similar industry obstacles in a closed-door, invitation-only setting. This unique forum brings together an exclusive

Webinar Replay: “Understanding What FDA is Looking for in Postmarket Safety Assessments: Going Beyond AERS”

As we know, getting a drug approved by FDA is hardly the last step. FDA’s oversight continues well past approvals and over the years, has become more vigilant regarding safety and efficacy. This greater focus means postmarket safety assessments are playing a growing and increasingly critical role within your regulatory group. During