Regulatory Affairs

RCCG professionals offer extensive knowledge and experience to help our clients develop and implement optimal medical product registration strategies and achieve efficient and successful product commercialization.

RCCG provides:

• Specialized consultants who are known and respected by US FDA and international regulatory authorities

• Expertise in regulatory submissions for medical devices, pharmaceutical, and biologic products in US, Europe, Canada, Pacific-Rim countries (including China, South Korea, Australia and Japan)

• Special expertise in regulatory affairs for drug/device and biologic/device combination products, tissue engineering, regenerative products, and complex biomaterials

• Optimized regulatory approval via critical path guidance to achieve business goals

• Service as our clients’ liaison with regulatory authorities from start to finish, helping to prepare and respond to regulatory authorities questions, and alongside them at US and international regulatory meetings

• Preparation of supplements and amendments to applicable existing regulatory and clinical submissions, including required annual and periodic reports

• Regulatory input during the entire product life-cycle