Regulatory Strategy Consulting
Representative
Agent and Regulatory Capabilities
Theradex® maintains excellent relationships with North American, Japanese and European
regulatory authorities. We provide the following services:
- Submission and Preparation of INDs
- Submission and Preparation of CTX/CTCs
- Pre-Study Country Regulatory Filings to National Health Authorities
- Preparation of Investigator Brochures
- Preparation of Chemistry, Manufacturing and Control (CMC)
- Preparation of Pre-Clinical Reports
- Preparation of Interim Study Reports
- Preparation of Investigational Plans
- Preparation of Drug Master Files
- Preparation of Drug Approval Dossiers
- Submission and Preparation of Annual Reports
- Conduct Audits in the Presence of Scientific Investigations Personnel
- Meet with Regulatory Agency Personnel to Resolve Questions and to Discuss Statistical
Analysis Plans for Multicenter Studies of Investigational Agents
- Attendance at Pre-Approval Site Audits
- Preparation and Review of 510(k) and PMAs
Complementing our global regulatory capabilities, Theradex® is able to act as the
United States Representative Agent for many of our Japanese and European clients,
who do not maintain offices in the United States. Acting as the Sponsor's Representative,
Theradex® can receive, transmit and file correspondence to the relevant national
regulatory authorities.