BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization's technical, manufacturing, analytical, and regulatory resources.
We are a team of professionals with expertise in process development, BioAnalytical services, process validation, project management, quality assurance, regulatory submissions and Pre-Approval Inspection (PAI) readiness. Our quality by design (QbD) approach enables us to effectively provide product development support, including: development reports, design of experiments, technology implementation, critical process parameter evaluation, technology transfer and scale-up, and on-site third party contract manufacturing support.
Latest BioTechLogic News
Meet BioTechLogic at These Great Events! - 2/25/2011
BioTechLogic will be participating in these upcoming events!
If you or your colleagues will be attending any of these events, contact us now to set up a time to meet and discuss how we assist companies with issues they encounter during the manufacturing and submission of their products.
Biopharmaceutical Development & Production Week
Hyatt Regency Hotel
2011 PDA/FDA Process Validation Guidance Workshop
JW Marriott San Antonio
Hill Country Resort & Spa
San Antonio, TX
May 22 - 25, 2011
Hynes Convention Center
BioTechLogic Invited to Speak on Panel - 2/24/2011
2011 PDA/FDA Process Validation Guidance Workshop: Aoril 13-14, 2011 JW Marriott San Antonio Hill Country Resort & Spa San Antonio, TX, USA
Kurtis Epp, Senior Manager, Manufacturing for BioTechLogic, will be presenting during Session P4 - Stage 3 Continuous Process Verification Implementation. The title of his presentation is "Post Approval Process Validation Reporting." He will be available to meet with interested parties during the conference.
The mission of PDA is to advance pharmaceutical and biopharmaceutical technology internationally by promoting scientifically sound and practical technical information and education for industry and regulatory agencies.
Brief from the PDA Workshop on FDA's New Guidance on Process Validation "The Shifting Paradigm in Process Validation" October 26-27, 2009 - 10/31/2009
Stage 1 (Process Design):
Stage 2 (Process Qualification):
Stage 3 (Continued Process Verification):
Developing a Sound Process Validation Strategy - BioPharm Magazine December, 2007 - Article written by BioTechLogic's Dave Fetterolf.
Highlights of WCBP 2008 Meeting in Washington, D.C. - BioTechLogic's Mike Rooney attended this U.S. FDA co-sponsored meeting addressing analytical/regulatory for biotechnology products and prepared this summary.