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

FDA 483: Does your business contain critical errors?

In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed quickly to avoid serious consequences. If not properly addressed, negative observations made during an FDA visit can ultimately result in suspended operations, bad press, scrupulous monitoring of operations, recall of products,