REGULATORY STRATEGY & DUE DILIGENCE SERVICES
Our compressive consulting services offer guidance and validation throughout each product development phase including strategy, compliance support, and due diligence.
Regulatory Strategy and Leading Regulatory Agency meetings (Like INTERACT, Pre-IND, EOP 1 and 2 meetings, Type C guidance meetings, Pre-NDA and BLA meetings, Scientific Advice with EMA (SAWP, EMA)), Liaison Services, Regulatory Submissions, Orphan Designation Strategy, and Regulatory compliance.