END-TO-END DEVELOPMENT

FROM FORMULATION CONCEPTS TO MARKET-READY PRODUCTS

Regulatory Affairs

From ideation to commercialized product, our expert regulatory team is engaged in designing and executing the regulatory strategy and guiding the product development and product lifecycle. By working with the Food and Drug Administration, we can ensure a seamless and streamlined execution from initial application to efficient maintenance of the submission lifecycle beyond approval.

Through effective communication with the FDA, our regulatory department obtains alignment to our strategic regulatory pathway. Additionally, the team actively contributes and comments on new and upcoming regulations and policies with the agency. 

We have a track record of more than 22 approved products (NDAs 505(b)(2) and ANDAs), which were successfully sold to a partner in 2015. Currently, there are five active INDs with the US Food & Drug Administration.

In addition, we actively continue to monitor regulatory intelligence and regulatory compliance.