Quality Systems News
March 2010
2 Peptide-Based Vaccine INDs Cleared by the FDA
We have successfully completed a platform and integrated quality system for the development and manufacturiing of peptides for clinical trials at a major research institution. The first 2 INDs have been accepted by the FDA. The highly cost effective and time efficient approach will enable several significant oncology programs to move forward.
Probiotic Vaccine IND Cleared by the FDA
Our partner-driven model was used to integrate formulation and production activities at a major research institution, testing at an external testing laboratory, and active ingredient production at firms in Belgium and Switzerland, all enveloped with comprehensive Type V Master Files, to lead to the clearance of a probiotic vaccine IND for the potential treatment of H1N1 influenza. Our Master File approach provided FDA with the information the Agency needed with content and a format to facilitate the review and build confidence in the manufacturing sites.
Protocols for Comparability of Human vs Xenotransplant Products
Need assistance to develop the right protocoll for comparability? Contact us, we have been developing these approaches since 1999, and have some of the most direct experience with FDA
CBER.
Could Nanotechnology Help Your Product?
Quality Systems will acquire a patent in the application of nanotechnology to solve a difficult formulation problem for a lead compound for the Department of Defense and Homeland Security. This breakthrough was responsible for more than $30 million in additional funding for a startup firm.
Respond to Your 483
Develop a proactive, thorough and responsive approach following visits from the FDA. Quality Systems has an outstanding record in developing and maintaining effective relationships with the Agency. View a recent FDA presentation.http://www.fda.gov/cber/summaries/pharma0109ar.pdf
Announcements
Quality Systems has recently expanded its offerings to now include full development of therapeutic peptides for Phase I/II clinical trials. Contact us to learn more about our very cost effective approach that will get your firm or institution into Phase I/II clinical trials