Combination Products

We can provide expert support for development of combination products based on practical experience across the wide range of disciplines needed for product development.

• Drug/Device expertise in development and commercialization of combination products. 
• cGMP guidance in implementation of regulations for device and drug manufacturers.
• Request for designation guidance.
• Regulatory authoring and filing expertise for combination products including 505(b)2 routes.
• Facility design and build for dedicated combination products.
• Expertise in highly unique combo products that are new to the FDA.