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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 . learn more complianceyou 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 . learn more 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 . learn more recent news & articles fda issues 67 new & revised bioequivalence study recommendations for generic drug makers 06 oct 2016 in order for a generic drug to be approved by the fda the drug maker must prove that the product ... read more fda redefines the term healthy in food labeling 05 oct 2016 on wednesday september 28th the fda issued a final guidance document regarding the inclusion of the term healthy on the ... read more self identification 101 everything you need to know about fda s self identification requirements for generic drug facilities sites & organizations 03 oct 2016 on thursday september 22 fda issued a guidance document entitled self identification of generic drug facilities sites and organizations . the document ... read more fda releases regulatory science priorities for medical devices in 2017 30 sep 2016 on thursday september 22nd the fda s center for devices and radiological health cdrh released its regulatory science priorities for fiscal ... read more contact the weinberg group inc. 1129 20th st nw washington dc 20036 p. 202.833.8077 f. 202.833.7057 contact us join our mailing list invitations to webinars new blog posts industry news updates join our mailing list follow us copyright 2016 the weinberg group inc. all rights reserved . privacy policy .