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 34 years, The Weinberg Group’s 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.

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.

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.