A consulting firm built around FDA experience

Who we are

We are a specialized consulting organization. Our work concentrates on quality systems, cGMP compliance, pharmaceutical development and manufacturing, validation and qualification, laboratory compliance and data integrity, investigations and remediation, medical device quality systems and clinical quality.

Engagements are staffed individually. Depending on what a client needs, a team may include a former FDA investigator, a validation specialist, a laboratory expert and a manufacturing quality professional — or it may be one experienced consultant on site for a week.

Compliance should work in the real world

Our founding conviction is that regulatory systems should be compliant and robust without becoming unnecessarily complicated. Organizations frequently struggle not because they ignore requirements, but because their internal procedures have become more burdensome than the regulations actually require.

A quality system that nobody can follow produces deviations, investigations and findings on its own. Our objective is to help organizations establish systems that meet regulatory expectations while remaining practical for employees to understand, implement and sustain.

Support across the product lifecycle

We support organizations from early development through scale-up, technology transfer, validation, commercial manufacturing and ongoing compliance. Compliance obligations do not begin at launch, and the decisions made during development frequently determine how difficult the later stages become.

How we work

• Direct, honest assessment of the current state, including what is already adequate
• Prioritization by regulatory risk rather than by ease of correction
• Hands-on implementation support, not recommendations handed over at the door
• Knowledge transfer so the organization can maintain the system independently
• On-site and remote support depending on the nature of the work