• FDA consultants in Washington DC
    WE’RE NOT A BUNCH OF GEEKS, NERDS, AND EGGHEADS.
    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
    ABOUT YOUR COLLEGE CHEM CLASS.
    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
    REMEMBER THE KID YOU PAID TO DO YOUR SCIENCE HOMEWORK?
    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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Outsourced Regulatory Affairs (ORA)

For a number of clients, The Weinberg Group conducts all regulatory activity for a fixed monthly fee. These clients enjoy the benefit of access to a multidisciplinary staff of FDA consultants whose expertise includes toxicology, pre-clinical, clinical, CMC, drug safety, medical, quality, global regulatory and project management. Benefits include milestone achievement, known costs and peace of mind.

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Project-Based Regulatory Strategy and Submissions

For the past 31 years, Weinberg Group regulatory strategies have provided the foundation for countless successful regulatory submissions. For each of our clients, our FDA consultants optimize the development process, reducing cost, diminishing time to submission and increasing likelihood of approval. For a majority of clients, we execute their strategy by developing submissions, preparing for and attending key FDA meetings and responding to Agency questions.

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Compliance

The Weinberg Group has 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 are priced competitively and have developed a unique fixed-price model.

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