OUR EXPERTISE
We are an elite group of former FDA and EU officials with subject matter experts in global regulatory affairs, quality assurance, and compliance. Moreover, we came from various industries, such as medical devices, biologics, in-vitro diagnostics, pharmaceuticals, and dietary supplements. In addition, we have experience with most, if not all, types of manufacturing processes and validations. Finally, we have an English-speaking call centre to support your customer support, technical support, medical reporting regulation (MDR) reporting, and complaint handling-related compliance.
Therefore, unlike other consulting agencies, we offer global regulatory, quality, and compliance under one management.
FULL SERVICE: A TO Z
Miracles Don't Happen in the Line of Our Business
In the manufacturing of medical devices, pharmaceuticals, biologics, and in-vitro diagnostics, we do not take a chance for risks. Our job is to make unquestionably sure that our manufacturing processes are validated so that no bad batch is released unintentionally. Indeed, we have opportunities to correct after the release, for example, by recalls, field correction, and even after receiving a Form-483 after the FDA inspection. However, they are proven to be not only ineffective but also resourceful.
Let us be your part-time contract employees to monitor your regulatory affairs, quality, gap analysis, and FDA compliance. We can see things from a different perspective and offer fresh insight.
Understanding one's culture makes a considerable difference.
This is especially true when applying to global compliance, understanding your staff, quality culture, and relevant laws and regulations. As such, we customize our approach to fit your culture when implementing quality and compliance.