GxPartners mission is to provide risk-based Quality, Validation and Regulatory Compliance staffing and consulting services for the Life Sciences Industry. Our Founding Partners have each been performing quality, regulatory, and validation services in support of Life Sciences clients throughout their careers, and are combining their knowledge to create a company capable of truly supporting the many needs of manufacturers in the Life Sciences Industry – primarily Pharmaceuticals, Medical Devices, and Biologics. PARTNERS – When you Partner with us, you are getting more than just a service provider. The Partners are: • Passionate – about being able to help our clients achieve goals and objectives while adding value • Advisors – The trusted advice you want delivered with the practical approach you need • Risk-based – Our teams and actions are focused on the areas that matter most • Trustworthy – The Partners have proven experience built on industry best practices with a track record of successful engagements • No Surprises – Clear communication throughout the engagement lifecycle • Expertise – Decades of experience supporting industry leading companies • Responsible – We treat your products and processes like our own • Sustainability – We provide solutions that can be implemented and seamlessly transitioned to your teams
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Attention Dental Product Manufacturers!!! The FDA has issued several guidance documents within the past few weeks for your products. See List Attached: Let GxPartners know if you need any support! We have extensive experience with Dental Device Regulatory, Quality, and Validation Services.
FDA released the Final rule for Laboratory Developed Tests (LDTs). Give GxPartners a call if you have any questions about the changes, the implications for your business, or if you need help with updating your Quality System and Process to comply with any of the Phaseout Stage (1-5) activities outlined in the Rule. https://lnkd.in/eNa34kDd
Updated Guidance from FDA/ICH on Analytical Method Validation, now published on FDA's Website!
FDA Guidance Document Issued for Human Gene Therapy Products incorporating Human Genome Editing.
FDA Guidance Issued for the development of CAR-T related products.
FDA announces Office of Pharmaceutical Quality reorganization to alleviate "long-standing pain points." https://lnkd.in/g582r8Pk