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

    “European Guideline on Carcinogenic Risk Evaluation Goes Into Effect in 2016″
    CEO, Matthew Weinberg, spoke to Drug Industry Daily about the EMA guideline on Carcinogenic Risk Evaluation, which will go into effect in January 2016.

    “EMA Q&A Guidance Provides Clarity on Adaptive Licensing Pilot Program”
    Matthew Weinberg, CEO, spoke to FDANews about EMA’s adaptive licensing pilot program.

    “How Outsourcing Can Accelerate the Drug Development Process”
    Our CEO wrote for Drug Discovery & Development about how companies that outsource their entire regulatory affairs function can accelerate the drug development process.

    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.