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?”
    Learn More

  • 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?”
    Learn More
  • Scientific Product

  • “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

    “Commentary: New trend in regulatory affairs consulting delivers reduced costs and improved processes”
    Matthew Weinberg, CEO, writes for the August issue of DDNews about a new trend in the regulatory affairs world, regulatory outsourcing. In order to deal with increased workloads, many companies are now outsourcing their entire regulatory function.

    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.

    Upcoming Events

    September 18, 2014, New Brunswick, NJ: The Weinberg Group will be exhibiting at the 13th Annual COntract Pharma Contracting and Outsourcing Conference. To set up a time to meet with us, please send us an email.