Development, Manufacture, Trouble Shooting and Regulatory Services

“We cannot direct the wind…but we can adjust the sails”

We are here to help you navigate through the US regulations to bring a safe product to the market.We are accountable for keeping up pace with the increasing complexity as well as the scope of the regulatory policies and guidelines. Our consultants assist with interpreting the laws and regulations for our customers. We can establish registrations and product licensing with the U.S. FDA, acting as a primary link between our client and the regulatory agency. Our consultants act as an extended team member on project teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle. We provide guidance and/or perform preparation and submission of routine regulatory applications, as well as internal regulatory file documentation and assist with developing and maintaining positive relationships through oral and written communication regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.