Independent Auditing

Services focus on ensuring regulatory compliance and optimizing processes for pharmaceutical companies, with expertise in FDA inspection preparation and comprehensive GxP auditing.

Regulatory Submissions

Services guide pharmaceutical companies through the complex US FDA regulatory landscape, encompassing IND to NDA/BLA applications, expedited pathways, regulatory meetings, and strategic labelling planning.

Advisory Consulting

Services encompass regulatory strategies, clinical and nonclinical designs, CMC planning, expedited approval pathways, labelling planning, and more, ensuring successful development in the evolving pharmaceutical environment.