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

Clinical Evaluation Reports (CER) –

Written by: Daniel Miranda, Globiox Consultant Clinical evaluation is a critical, ongoing task that must be performed by medical device manufacturers who market products in the European Union and seek to obtain or maintain a CE mark. This task is completed via creation of a clinical evaluation report (CER). A CER must be created prior

Regulatory

Globiox’s team of consultants collectively, have experience in navigating regulatory pathways for a variety of life sciences products including drugs, medical devices, and combination products in both the United States and the European Union.  The regulatory landscape is constantly evolving, and Globiox prides itself on staying in tune with the latest developments.  Here is a

Validation

Validation is critical to ensure data and process integrity. Validation should not be a paperwork exercise but should be carefully planned based on risk and statistically sound sampling plans. Validation done right adds value. Globiox has experience in resolving 483s and Warning Letters that have resulted from inadequate validation programs. Our Services include: Computer System

Vendor & Supplier Management

Since outsourcing is so popular, vendor and supplier management has become more resource intensive. To combat this, many companies now outsource vendor and supplier qualification and management. Globiox can manage the complete vendor and supplier audit program or perform audits and assessments for an internally managed program. Over the past year, Globiox auditors have uncovered

Deviations and CAPA

DEVIATIONS AND CAPA With lean work forces, FDA-regulated companies may find themselves with a backlog of deviations to be investigated and CAPAs to be resolved. Faster resolution using outsourcing results in less business, technical, patient, and regulatory risk. Globiox can take the pressure off and help the company to resolve its problems and meet its

Quality Management Systems

Globiox’s team of experts can assist you in nearly every facet of the simplest paper based quality management system (QMS) to the most advances electronic quality management system (eQMS). Our clients include Fortune 500 companies and start-ups alike. We have expert staff to handle it all in a mutually agreeable scope. Gone is the time