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"cGMP policies facilitate the application of modern quality management techniques and quality systems to all aspects of cellular therapy production." |
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cGMP Consulting and Regulatory Services |
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| Our Understanding |
More than ever before, our clinicians and researchers are challenged to bridge the gap from "Bench to Bedside" as our nations seek therapeutic application of recent breakthroughs in science and technology. The application of stem cell research is at the forefront of this trend, and is widely regarded as a new era in medical treatment. As a leading nation in this field, India is poised for major breakthroughs attracting international interest by both researchers and the medical tourism market. To navigate this transition successfully, TotipotentSC has the experience in medical regulations and manufacturing practices to make guide this transition.
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| Regulatory Support and Project Planning Integration |
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| A Unique Solution |
TotipotentSC is compliance focused and understands the regulatory climate put forth by the key global agencies. We can provide the guidance and expertise to ensure that you comply with current Good Manufacturing Practices, and provide turn-key solutions to your needs. |
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| Portfolio of Services |
Human Cells, Tissues, Cellular and Tissue based Products
cGMP, cGCP, and cGTP Planning and Implementation |
• Process strategy / optimization / scale-up
• Point-of-care manufacturing
• Outsource manufacturing
• Turn-key facility design and installation
• Quality system development/optimization |
• Validation guidance for manufacture, quality procedures and • shipping
• Regulatory compliance review and recommendation
• International compliance for Medical Tourism |
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