For the past 31 years, The Weinberg Group has assisted pharmaceutical and biotechnology 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?”
    Learn More

  • Recent News

    Éclat Receives FDA Approval for VAZCULEP™
    Congratulations to our client, Éclat, on the recent FDA approval of the company’s New Drug Application (NDA) for VAZCULEP™ (phenylephrine hydrochloride injection)! Read the full press release here.

    “Bill Tying FDA Review Timelines to EU Approvals Questioned”
    CEO, Matthew Weinberg, spoke to in-PharmaTechnologist about the Speeding Access to Already Approved Pharmaceuticals Act, which would require FDA to begin reviewing drug candidates within 90 days of EU approval.

    “The Clock is Ticking”
    CEO, Matthew Weinberg, writes for Tobacco Reporter about FDA’s proposed e-cigarette regulation and urges stakeholders to take advantage of the opportunity to respond.

    “Cheaper biotech drugs and risk appetite — is a rose by any other name a rose?”
    Dr. Nick Fleischer, Vice President, and D. Bruce Burlington discuss the naming of biosimilar drugs on PharmaPhorum.