For the past 30 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.

Regulatory Strategy
and Submissions

  • “What is the optimal regulatory strategy for my new small molecule?”
  • “Are you able to help us prepare the briefing package for a pre-IND meeting with FDA?”
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    Compliance
              

  • “Can you complete 100 GCP audits across the world in the next six months?”
  • “How should I respond to a Warning Letter regarding issues at our manufacturing plant?”
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    		•

    Scientific Product
    Support

  • “How can I estimate the regulatory risk of acquiring a new device?”
  • “We just acquired a new company. Can you provide a regulatory/ compliance assessment of its practices?”
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    		•

    Recent News

    We are hiring!
    The Weinberg Group is expanding and hiring for many roles! See our careers page for more information.

    Weinberg Group Tweets

    "#FF some valuable #FDA handles @US_FDA @FDA_Drug_Info @FDACBER @FDADeviceInfo @FDAcdrhIndustry"
    "#FDA new and generic drug approvals up until 5/15: http://t.co/iZ9LemFv0M #pharma"
    "The 505(b)(2) NDA Pathway – An Innovative #FDA Strategy that Everyone Should Understand: http://t.co/8AHL4UbRB0 #webinarreplay"
    "Did you miss our webinar yesterday? DM your email and we will send you a copy of the slides!"
    "FDA Provides Guidance on Use of Electronic Health Data, Pooled Data in Postmarketing Studies: http://t.co/AqELQSqwZ7 via @RAPSorg"
    "MT ‏@SarahKarlin reminder from #FDA: Deadline (May 31) for FY 2014 Self-Identification for Generic Drug Facilities, Sites & Orgs Approaching"

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