Safely Processing Regenerative Medicine Tissue
As we all try to cope with the trying times the world is going through, we want to assure you that New Life is committed to providing safe and clinically effective regenerative medicine products while remaining cognizant of the rising cost of healthcare. Our goal is to improve the quality of life for those individuals suffering from pain, injuries, aging and, sometimes, just from the effects of day to day living.
Ensuring a High-Quality Product
Our revolutionary regenerative medicine products utilize the natural healing components contained in birth tissues that may enhance the body’s natural ability to heal. With our primary focus on quality assurance, New Life is dedicated to providing a high-quality, safe, and effective product for clinical use.
Consenting donors are tested under standards established the FDA’s Title 21 Code of Federal Regulations, part 1271, subpart C (21 CFR part 1271, subpart C) (Ref. 1) to ensure the donor (expectant mother) is healthy with no pregnancy complications.
All processing is performed in an aseptic environment in a cGMP certified laboratory, which follows the guidelines of both the FDA and AATB. The FDA requires minimal manipulation of the structural tissue without processing it in a way that affects key characteristics, such as strength, flexibility, cushioning, or covering. During processing, we abide by the FDA’s guidelines, performing tests on our products to demonstrate the absence of bacterial and fungal contamination without manipulating the product and diminishing its key characteristics.
The FDA requires a clear and concise instruction label of the specific product, how it is to be used, and recommendations regarding the packaging and storage of the product. At New Life, we follow the FDA’s guidelines and include instructions for use, product stickers, and a tissue utilization report card in each package. Additionally, we include an application guide for recommended product use and mixing as well as a quality assurance form verifying that each order has been checked for accuracy before departure.
New Life as an Industry Leader
In addition to providing a high-quality and safe product, New Life also provides clinical support and training. Our team of Medical Directors are at the top of their fields and recognized nationally and internationally for their skill and expertise. As industry leaders, we offer Regenerative Medicine Training Sessions to help practitioners stay ahead of the proper protocols, procedures, and techniques surrounding the regenerative medicine industry.
As the FDA regulations and industry standards change frequently, we want to educate clinicians so they can successfully implement and maintain their regenerative medicine practice.
If you have any questions on New Life products or are interested in implementing regenerative medicine into your practice, please visit https://www.newliferegen.com/contact/.
