SDG, LLC assists FDA-regulated industry in the development and implementation of economically efficient, FDA-compliant clinical and regulatory strategies. We provide the following key services:
- Full startup regulatory support for new companies in planning and implementing pre-IND and pre-IDE meetings.
- Clinical planning and regulatory support for Phase II and Phase III clinical trial design, review and presentation.
- Planning and strategic support for NDA submission and for presentations at Medical Advisory Committee meetings.
- Support for all aspects of remediation and salvage of programs with unanticipated complete response letters and compliance issues.
Please contact us to inquire about our services and expertise.