The Drug & Device Development Co., Inc. founded in 1985, has expertise in the regulatory, clinical, quality and statistical aspects of drug, biologic, diagnostic, and medical device development. The DDD group consists of both full-time and part-time specialists. Each one is well experienced in one or more aspects of the drug, biologic and/or device approval process.

The major focus of DDD's services is related to product approval support. Services include the following: regulatory and clinical strategies and implementation for pre-market submissions, pre-clinical and clinical study design, protocols, monitoring, clinical auditing, data entry, database management, statistical analysis and evaluation, report writing and training. DDD assists companies in setting up Design Controls, ISO and GMP compliance programs.

DDD has an excellent reputation in the regulatory and clinical community, as well as productive and result-oriented relationships with various divisions of the FDA.

A more detailed description of our services follows. Also included are typical client profiles and a list of product types demonstrating DDD's experience.