Intertox, Inc. services

Intertox assessments range from catastrophic chemical releases to minute parts per quadrillion levels of pharmaceuticals and endocrine disrupters in drinking water. We have unique experience with examining thousands of different chemicals and their potential impact on human health.

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.

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.