Combination Products

The challenges involved in the development, manufacture, and regulation of combination products can be exponentially more difficult than those faced by the drug or device alone. PharmaNet/i3 professionals can assist in their development, having been involved in designing and conducting clinical trials for combination products; assisting with manufacturing issues; preparing and submitting marketing applications for these products; and helping to develop the approach taken by international regulatory agencies to combination product jurisdiction, regulation, and technical/clinical evaluation.