ENG ES

Regulatory Support

SUPPORT AND VALUE DURING ALL STAGES

Our Team works closely with our customers to understand expectations and develop a regulatory strategy that guarantees the best quality, timely submissions, and faster, positive registration outcomes.

We also count with experience preparing submissions in eCTD Format, and provide support during the application phase and beyond, including annual reports and other post approval submissions.

We have proven expertise in technology transfers, product launches, product development and manufacturing technologies, helping our customers overcome formulation challenges.