For the past 30 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

    “Expert: ‘We lack the regulatory models’ for next generation drugs”
    At the 2014 DIA Euromeeting, Matthew Weinberg, CEO, spoke with about future challenges to the pharmaceutical industry.

    “Common misconceptions about the orphan drug designation”
    Jeff Antos, Vice President, writes for the March/April issue of Pharmaceutical Commerce about the orphan drug approval process.

    Upcoming Events

    May 19-21, 2014, Budapest, Hungary: Dr. Nick Fleischer, R.Ph.,Ph.D., Vice President, will be presenting during Day 3 (5/21/14) of the 4th International Regulatory Workshop on “505(b)(2) New Drug Application Pathway vs. Abbreviated New Drug Application Pathway for Drug Approval in the US.” To set up a meeting during the show, please send us an email.

    June 15-19, 2014, San Diego, CA: The Weinberg Group will be in the exhibit hall (booth 2519) at this year’s DIA Annual Meeting. In addition, Jeff Antos, Vice President, will be speaking during the session titled “Utilizing 505(b)(2) in Clinical Bridging Studies to Accelerate Drug Development Plans.” To set up a meeting during the show, please send us an email.