Regulatory & Clinical Affairs

Unparalleled expertise, with a record that speaks for itself. Four dermatology NDA's in less than two years!

The regulatory pathway to FDA approval for dermatology products differs from those available for other therapeutic areas, and early development of proper strategies can shorten timelines and reduce costs. The Dow Regulatory & Clinical Affairs Department is sharply focused on designing dermatology-specific strategies which will speed development while managing risk, relying on vast experience with the FDA’s Dermatology Division and utilizing cutting edge submissions tools.

Experience with Success

Your drug development program will benefit from our 30 years of topical product development experience. Dow has written and submitted numerous INDs, NDAs, and IMPDs, and prepared a wide variety of topical product development plans, non-clinical and clinical protocols, Investigator Brochures, CTAs, CTDs, and PMAs. 4 NDAs were submitted in 2003-04; all 4 were approved in 2005-06.

Focus

Your topical program will benefit from the many years of successful experience that Dow has interacting with the FDA’s Dermatology Division on behalf of its large client base. Dow is that Division’s most frequent visitor. This face-to-face contact with FDA allows Dow first-hand knowledge of any trends in guidance changes, so we can steer you away from pitfalls and toward approval as quickly as possible.

Flexibility

You can choose how to work with Dow as we provide regulatory guidance at all stages of product development. From consulting services to preparation of product development plans to submission of INDs and NDAs, Dow provides the full spectrum of regulatory support.

Speed

When it is time to file your IND or NDA, Dow will compile and submit as quickly as is possible. The Dow Regulatory team was the first to submit and gain approval of an NDA submitted electronically to the Dermatology Division of the FDA, and utilizes state-of-the-art Core Dossier software for compilation and submission of a variety of documents. FDA continues to push for submissions in electronic format (Paper Reduction Act of 1995), and documents submitted electronically may be reviewed in less time.

To Learn More

About our Non-Clinical Services
Information on Submissions & Publishing