Our global regulatory strategy and product development consulting service partners with our clients to help them mitigate risk. When it comes to developing regulatory strategies, we are experts in examining the nuance which enhances the potential of making the product successful.
Our team has substantial experience with all facets of the international regulatory approval and clearance processes including:
Our strategic consultations employ key knowledge in the area of Regulatory, Clinical, Product Design, Quality Compliance, Commercialization, and overall development feasibility.
Our experience with the FDA and EMA/Notified Bodies as well as key regulatory agencies around the world (e.g., Health Canada, TGA-Australia, DCGI-India, PMDA-Japan, NMDA-China) provide a starting point for developing a regulatory pathway that will evolve into a full development strategy. Partnering with our clients across the development pathway is our goal while providing the nimbleness to utilize our expertise as required in a flexible and scalable model.