June 2025

In our consulting work we have helped out many companies.  They span the gamut of knowledge of FDA regulations and general business experience.  Most of them are struggling with the regulations (Go figure.  That’s why they call us.)  So, if you’re struggling with regulatory compliance, you’re in a very large club.  Don’t feel bad.

There are, however, companies who are not struggling.  Not many, but we’ve seen enough of them to recognize a pattern.  These companies are rolling on a virtuous cycle of quality.