Track Record
Universal Regulatory Inc has assisted clients across the US, European Union, and Asia in accomplishing key regulatory milestones. Below is a representative selection of recent engagements.
Provided comprehensive regulatory strategy and submission support for a small pharmaceutical company seeking NDA approval for a specialty drug product. Coordinated all technical sections and managed agency interactions through approval.
Led regulatory strategy and IND preparation for a biotechnology company developing a novel biologic therapeutic. Coordinated nonclinical, clinical, and CMC sections to support first-in-human studies.
Supported preparation of a Marketing Authorization Application (MAA) for submission to the European Medicines Agency. Provided strategic guidance on EU regulatory requirements and coordinated scientific advice procedures.
Prepared and facilitated a Type B End-of-Phase 2 meeting with FDA for a mid-size biotechnology company. Developed meeting briefing document, anticipated agency questions, and provided strategic guidance on Phase 3 program design.
Provided CMC regulatory strategy and submission support for a pharmaceutical company seeking approval for a complex drug product. Addressed agency questions and supported manufacturing change supplements.
Served as Interim Vice-President of Regulatory Affairs for a biotechnology company during a critical development phase. Provided leadership across all regulatory functions and managed a team of regulatory professionals.
Contact us to discuss how Universal Regulatory Inc can support your next regulatory milestone.
Contact Us