What Differentiates Us

Every member of our team has extensive industry experience.  Within the course of our collective careers, we have solved the same issues that now challenge you and your team.

We work closely with your team so they can acquire new skills and successfully address significant future challenges.

While others may tell you why you must solve a problem in a certain way, our collective experience enables us to provide you with choices in addressing any given situation.

We won’t always advise you to change your operational approach to match the opinion of a regulatory authority but are often successful in convincing the regulators of the merits of our clients’ points of view.

Our Experience is What Makes the Difference.

We have worldwide experience with a client base that extends from the Americas to Asia to Europe to the Middle East.

We have helped our clients resolve Consent Decrees, Import Detentions and Warning Letters.  We have obtained market clearance for novel new technologies. We have helped small start-up companies successfully navigate US FDA Pre-Approval Inspections and gain access to the US market.  We have helped our clients solve serious product quality problems.  We have helped to develop and design new manufacturing processes and have validated these processes.  We have served as adjunct management during times of regulatory or quality crises.