A Lot Is Riding On a NDA Submission

Aug. 3, 2012 - PRLog -- Companies routinely invest millions in developing new drugs and therapeutic devices. Then it comes time for the New Drug Application (NDA) process in which the FDA rules thumbs up or thumbs down.

In order to be approved, documentation must be submitted with an NDA that speaks unambiguously to the drug’s safety, effectiveness, benefits, and risks. Additionally, the FDA will scrutinize the conditions under which the drug is manufactured, to making sure they maintain the drug’s quality and safety. Finally, the regulatory agency will look at proposed labeling to ensure it gives healthcare providers and consumers the information they need to make informed decisions about use.

One cannot skimp when it comes time to formulate their NDA submission strategy. The regulatory consulting experts at the Weinberg Group are experts at analyzing each component of the application process to pinpoint and remediate information gaps. The Weinberg Group ensures the planning processes stay on track, evaluating both anticipated and unanticipated risks, and helping each company find ways of mitigating those risks. The experts at the Weinberg Group can also help a company fast track their product should circumstances warrant it through expeditious use of the 505b 2 process.

Good manufacturing practices (GMP), and a GMP consultant, must be in place before an NDA will be approved. Often, this is the hardest part of the NDA submission process since it is likely a company may have little or no oversight over manufacturing partners. A drug will not pass review if the conditions under which it is manufactured are found to violate manufacturing guidelines. For more information about the Weinberg Group and the many compliance consulting services it provides, companies should visit http://weinberggroup.com/.


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