You develop the product. We plan and help implement the health and safety strategy and risk assessment studies required to get it to market. Few companies have the breadth of regulatory expertise as Intertox. We provide domestic and international regulatory affairs services for medical devices, in vitro diagnostics, pharmaceuticals, and combination products.
Product Development Services
- Strategic Planning – Develop approval strategies including chemistry, manufacturing and controls (CMC), and non-clinical and clinical programs.
- FDA Liaison – Provide guidance and/or serve as a direct liaison with the FDA for the coordination of Prescription Drug User Fee Act meetings.
- Non-clinical Regulatory Support – Manage Investigational New Drug Applications’ toxicity studies, associated non-clinical safety studies, and biological activity programs to support clinical investigations and marketing authorization.
- Clinical Regulatory Support – Develop clinical investigations to establish safety, proof-of-concept, and efficacy sufficient to support marketing authorization.
Marketing Authorization Submissions
- Regulatory Submission – Prepare all regulatory approval documents in compliance with Common Technical Documents (CTD) requirements including electronic CTD (eCTD) submission to the FDA.
- Prior Approval Inspections – Assist with the preparation and participation in the FDA prior approval inspections and oversee corrective actions as required.
- Labeling Negotiations – Negotiate with regulatory authorities regarding product labeling, advertising, and promotional materials.
Post-approval Life-Cycle Management
- Post-approval commitments – Support compliance with FDA post-approval commitments including CMC and Phase IV Clinical Trials.
- Post approval supplements – Manage regulatory strategic development, preparation, submission and management of post-approval product modifications, including labeling, advertising and promotional materials.
International Regulatory Support
- International registration dossiers – Provide guidance and support for the development, preparation, and submission of International regulatory marketing authorization submissions.
- U.S. FDA Agent - Act as a U.S. Regulatory Designated Agent for international organizations and serve as a direct liaison with the FDA. We also submit required documentation for establishment and product registrations.