Medical Device Regulatory Services

Intertox helps clients comply with FDA rules through all phases of developing new medical products and bringing them to market. Our A to Z services include strategy, planning and, when needed, oversight to ensure that the medical product meets or surpasses what the FDA requires of it. We also provide marketing, authorization and product life cycle management programs.

Clients often ask us to help them with the various stages to develop:

• Medical devices,
• In vitro diagnostics,
• Companion diagnostics,
• Pharmaceuticals, and
• Combination products.

Intertox helps clients with regulatory approval through all stages of product development. Among our services are:

• Strategic Planning – We help clients build a plan  to win FDA approval, including Chemistry Manufacturing and Controls and  non-clinical and clinical programs.
• FDA Liaison – At times, clients need us to serve as  a direct liaison with the FDA or to provide guidance to coordinate  Prescription Drug User Fee Act meetings.
• Non-clinical Regulatory Support – Clients needing  investigational new drug applications turn to us. We conduct toxicity  studies, associated non-clinical safety studies and biological activity  programs.
• Clinical Regulatory Support – We design and stage clinical trials to show safety, proof-of-concept and efficacy in order to win approval to begin sales.

Once a product is ready to be submitted to the FDA, we offer services to help them at every step, including:

• Regulatory Submission – Our team prepares documents  that comply with Common Technical Documents (CTD) requirements,  including electronic CTD submission.
• Prior Approval Inspections – We help clients  prepare for and be part of FDA prior approval reviews. When the FDA  orders changes, we guide the client through the process and what it must  do.
• Labeling Negotiations – We help clients through the each step to win approvals for product labeling, advertising and promotional materials.

Our work with clients continue after the product has been launched. We provide services in two key areas:

• Post-approval commitments – Once a product has won FDA approval, we help maintain compliance, including CMC and Phase IV Clinical Trials.
• Post approval supplements – When changes come after approval, we step in to help manage the process

We help our clients take their products global. We also work with foreign companies who need regulatory help in the US.

• International registration dossiers – We help  clients take their products global. We work with them to develop and  submit materials to gain international regulatory marketing  authorizations.
• FDA Agent – Foreign clients sometimes ask us to act  as a U.S. Regulatory Designated Agent. As such, we serve as a direct  liaison with the FDA. In that role, we also manage and submit key  documents.