• FDA consultants in Washington DC
    Those guys didn’t make the cut. We are strategists, thinkers, ideas makers, and problem solvers. And, as the world’s leading FDA consultancy, we know what it takes to achieve your business objectives.
  • FDA consulting services – regulatory compliance & submissions
    We’re the brainiacs who wrecked the curve. Our FDA consultants are experts in science, medicine, ethics, and regulations. With this unparalleled knowledge, we create intelligent solutions that help you reach your drug and device development goals.
  • FDA approval process consultant
    He’s still in business. Passion. Excellence. Intelligence. These are just a few of the qualities we embody. And because of this unique mix, we continue to be the global leader in regulatory consulting services.

FDA Guidance Alerts

The Weinberg Group frequently opines on FDA actions, guidance and decisions. Our blogs and webinars are anticipated and read by pharma/biotech executives worldwide. Join our mailing list to receive alerts for this valuable content.

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Project-Based Regulatory Strategy and Submissions

You are developing your products with the intention of marketing, licensing, or divesting. To accomplish your objectives, you need to get through FDA.  Whether an NDA, BLA, ANDA or PMA, every step in your process is critical and expensive.  Doing it right isn’t the goal; it’s the only outcome that counts.  That’s where we come in. For the past 31 years, Weinberg Group regulatory strategies have provided the foundation for countless successful regulatory submissions. We succeed because we combine science and regulatory knowledge.  We know that you have products with unique characteristics and we use those to further their development.  We optimize your development process, reducing cost, diminishing time to submission, and increasing likelihood of approval. Our decade’s long history of success is testament to the impact we can make for you and your firm.

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You need to be compliant in manufacturing and in clinical trials.  Failure to do so has enormous and expensive consequences.  We help make sure that doesn’t happen.  We have a full range of compliance services, including quality systems review, GLP, GMP, GCP audits, and remediation for those companies that must respond immediately to compliance issues. Weinberg Group audits are conducted by experienced professionals worldwide who produce audit reports with the highest levels of accuracy and consistency. We have developed a unique fixed-price model, which makes fees easy to predict and understand.

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Outsourced Regulatory Affairs (ORA)

Regulatory work is never-ending.  Getting it right is critical for your products.  The range of needed skills is vast and many of our clients use a number of consultants to accomplish regulatory objectives.  There is a better way.  The Weinberg Group pioneered the outsourcing of all regulatory activities.  Let us do what we do best, helping develop your products as quickly as possible.  For a number of clients, we conduct all regulatory activity for a fixed monthly fee.  You enjoy peace of mind knowing that all necessary filings, submissions, annual reports and communications are covered and correct.

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