Professional Regulatory Advice Solid Scientific Underpinnings
Regulatory Affairs Experts The processes of global regulatory affairs consulting via which a drug can be authorized are well-defined. Sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics Act contain information that is necessary for determining which regulatory pathway is best for your drug development program. This is why we routinely lay out a regulatory plan at the outset of a project, even if it seems unnecessary. Regulatory affairs experts have helped in the creation of numerous pharmaceutical and biomedical products. Many of our clients have relied on us from the earliest stages of development all the way through the approval process and beyond. Sponsors submit this while seeking FDA approval for an investigational novel medication that has an active component that has not yet been studied. Clinical and nonclinical studies, as you might expect, are essential for this type of submission since they prove the product is safe and effective for the intende...