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Nano scale pharmaceuticals and medical devices show great promise in various applications for health care. Many nano scale pharmaceuticals have already been approved by the FDA. Nano scale materials can be used as ‘delivery’ mechanisms allowing cells to absorb therapeutics into the cell wall. Various nano materials are being researched for use in cancer therapeutics. Nano scale wires and needles are being researched and developed for use in epilepsy and heart control.

All of these medicines and medical devices will need to pass many rigorous testing protocols for approval by the FDA (and their counterparts in Europe, Japan, etc.) before being allowed for sale.

nanoTox has the experience working with FDA to design and implement pharmaceutical and device testing protocols and satisfy FDA requirements for approval. Especially for smaller and midsized companies that are developing novel nanomedicines and nano medical devices, our experience can reduce the overall cost of regulatory approval and shorten time-to-market.
Nanotox is able to:

  • • Advise in the early stage design and development of nano-enabled medical devices and pharmaceuticals
  • • Develop effective and efficient strategies for development, approval and commercialization of medically oriented nanoproducts
  • • Assist with and/or prepare of CMC sections for pharmaceutical applications involving nanomaterials.
  • • Perform third party quality audits of manufacturing and testing facilities (GLP and cGMP)
  • • Develop and conduct  nanomaterial characterizations for use in medical devices and therapeutics.
  • • Can fully establish and oversee non-clinical safety evaluations for medical nanoproducts including:
    o Design, cost analysis and placement of comprehensive testing programs  in accordance with FDA guidance,
    o Conduct and/or oversee work on all non-clinical studies required for FDA submissions
    o Provide expert summaries of test results as well as collect and analyze relevant literature data;
    o Prepare non-clinical sections for all types FDA applications involving the use of nanomaterials
    o Respond to inquiries by FDA in a professional, effective and timely manner;
    o Correspond with FDA on non-clinical matters involving nanomaterials.
  • • Can assist with dose characterization and analysis for human clinical trials
  • • Advise on the design, placement, cost negotiations and placement of human clinical trials
  • • Prepare the manufacturing and non-clinical portions of clinical study brochures and formal submissions.
  • • Assist with post approval changes and provide third party, post approval, audits and problem investigation support.

 

 
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Published Articles

Fact Sheet for Nanotechnology under the Toxic Substances Control Act | Prevention, Pesticides and Toxics (OPPTS) | US EPA
EPA