Written by: Patti Rossman Preparing for a REMS (Risk Evaluation and Mitigation Strategies) audit can be a daunting task, but with the right approach, it can be manageable and even straightforward. Whether you are a vendor or a service provider, ensuring compliance with REMS requirements is crucial for maintaining regulatory standards and delivering quality services.
Category: Regulatory
Staying Ahead: Navigating Timely Training and Version Control in Pharmaceuticals and Medical Devices
written by: Jenny Azarh In the dynamic world of Pharmaceuticals and Medical Devices, maintaining regulatory compliance and ensuring the highest standards of quality is crucial for ensuring patient safety. Throughout 2023, Globiox auditors conducted over 40 quality audits, revealing a recurring issue within the industry: overdue training and delayed training acknowledgments. This common challenge underscores
Globiox Stands Up and Stands Out at Biofest Invest
Globiox, a premier quality assurance firm, takes the stage as a presenting sponsor of Biofest Invest, reaffirming its commitment to innovation, growth, and collaboration within central Texas’ vibrant life sciences ecosystem. San Antonio, TX – Globiox, a technical quality assurance consulting firm headquartered in Austin, Texas, announces its role as presenting sponsor for Biofest Invest,
September Office Hours At The University of Texas Dell Medical School CoLab
We are now offering office hours at The University of Texas Health CoLab to meet with aspiring life science companies for 1 hour consultations (FREE) regarding Quality Management Systems, GxP Audits, Regulatory Strategy, Operations Support, Information Technology, Computer System Validation, Equipment Qualification, Facilities Qualification, and Clinical Services. ***Reservations are made through the dellmed.utexas.edu website (provided
Challenges of the Medical Device Market for New Manufacturers
Written by: Andrey Grishin, MD, Globiox Consultant Ensuring Quality of the Final Product. Every Medical device manufacturer must guaranty high product quality to avoid costly product recalls and legal issues which can also pose risk to the public. Product recall negatively impacts its brand reputation and the company’s bottom line. Ensuring required product safety, security
Globiox’s Office Hours at The University of Texas Health CoLab
Globiox is excited to announce office hours at The University of Texas Health CoLab to meet with aspiring life science companies for 1 hour consultations regarding Quality Management Systems, GxP Audits, Regulatory Strategy, Operations Support, Information Technology, Computer System Validation, Equipment Qualification, Facilities Qualification, and Clinical Services. ***Reservations are made through the dellmed.utexas.edu website (provided
Latest Updates on Regulatory
Written by: Andrey Grishin, MD, Globiox Consultant With the recognition by the US Food and Drug Administration (FDA) of last country-member Slovakia just a few weeks ago, the European Union and the United States have now fully implemented the Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective
FDA plans major overhaul, looks to be more specialized
5 months ago the FDA announced that in response to “unparalleled challenges” posed by advances in science, globalization and product complexity, the agency would need to realign its programs. With very little detail it was revealed that it would be led by a Program Alignment Group (PAG) consisting of all executive-level members of each of