Technical and Regulatory Writing

Our partners can assist your organization with regulatory strategy development, provide services for local and national regulatory agency submissions, and keep you in compliance with reporting requirements for each geography. Our regulatory consulting services includes country submissions (US and xUS), Central/Local IRB/IEC Submissions, regulatory reporting, support for FDA pre-sub meetings and filings, FDA panel support, regulatory audit preparation/support, special status filings with FDA such as breakthrough designation and STEPs.