Touchstone Technologies is a Regulatory Auditing, Consulting, and Training firm that specializes in Healthcare Pharma, Biotech, Food, and Medical Devices industries.
Our goal is to help your company stay compliant with FDA, CLIA, CAP and other domestic and international Regulatory Agencies requirements.
Auditing provides management with information about how effectively the company controls the quality of its processes and products. Our Auditors provide information on gaps between a company’s processes vs. regulations such as USFDA cGMP, Data Integrity, CLIA, and CAP. Regulations and other quality standards like ICH Q10. Our Auditors can then make recommendations on solutions to potential issues, support the company with the remediation of those issues, and be available to support a company during an inspection.
Our Consultants ensure that companies follow applicable government regulations such as USFDA, EMEA, CLIA, and CAP regulations. Their tasks include ensuring that company employees are familiar with applicable regulations. They may also consult with staff on different projects to ensure that production methods or design plans will comply with regulations.
Our consultants will often take a leadership role in developing policies that are designed to maintain regulatory compliance. They may establish procedural guidelines. Their duties also involve gathering reports and paperwork that is required to demonstrate that their organization follows the applicable regulations and may also submit materials to government agencies as required.
We offer on-site and web-based training services on the most pressing issues that the industry is currently facing. The online training is more generalized, keeping in mind the audience who attend from different companies. If a client is looking for something more customized, we do offer customized online training and customized on-site training.
Touchstone will undertake a complete end to end project delivery to meet client requirements. Our personnel will interview the client and then undertake the responsibility for the essential design of the product/project. Touchstone would only request client participation where the client either prefers to participate or where the client has essential data knowledge that cannot be supplied by Touchstone; this reducing client time required for a project. Touchstone may deliver such a project/product, with Touchstone personnel, or by working with one or more of our excellent partners, that bring in-depth expertise to each specific situation. Further, at the client’s agreement, Touchstone may outsource the work to non-US personnel, to reduce product/project costs.
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