Built by people who used to run the inspection

Where it started

Before founding the firm, Dusty Snoeberg-Renwick conducted pre-approval, cGMP and GCP inspections for the FDA and was regarded inside the Agency as an expert in process validation. In industry she helped extricate the first medical device firm ever placed under a Consent Decree. Both experiences pointed at the same problem: most compliance trouble does not begin with companies ignoring the regulations. It begins with well-intentioned internal procedures that nobody on the floor can actually follow.

What we set out to change

Regulatory systems should be compliant and robust without becoming unnecessarily complicated. A quality system that is too heavy to execute generates its own deviations, its own investigations and eventually its own findings. The firm was built to design systems that satisfy the regulation and survive contact with the production floor.

How the team grew

Rather than scale into a large generalist consultancy, the firm added depth: former FDA investigators and compliance officers, senior validation and laboratory specialists, computer system validation professionals, and clinical quality experts. Engagements are still staffed individually — sometimes a full multidisciplinary team, often one experienced consultant on site for a week.

What has not changed

Direct assessment, prioritization by regulatory risk, hands-on implementation, and knowledge transfer so the organization can carry the system forward without us.