Synergy for Quality


Our approach to compliance is based on a thorough understanding of the requirements and expectations of the governing bodies. Inherent in the expectations of the regulatory bodies is the proper interpretation and application of the GxP Requirements to each system or subsystem, being assured that it can consistently meet or exceed requirements for product safety, efficacy, and quality.

There is not one specific way to achieve this, but the solution applied must show that the regulatory expectations have been satisfied. The penalties can be very high for not complying with the regulation and expectations, not having necessary testing and documentation, and in turn not having adequate assurance that the process produces a product meeting specifications and quality attributes.

The GxP requirements in the areas of GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), GLP (Good Laboratory Practice), and GDP (Good Distribution Practice) are becoming global. Requirements of regulation come from guidance of the FDA and such agencies as the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, the European Medical E Agency, and the Japanese Ministry of Health, Labour, and Welfare. We stay abreast of the agency expectations in the United States and Internationally and the guidance of organizations such as GAMP Forum, ICH, ISO, and ISPE that establish the industry standards.


Industries We Serve

Compliance Approach

We base our approach to compliance on the current industry guidance and methods and we strive to understand the fundamentals of everything that we do, read more

Industries We Serve

Project Strategy

We believe that successful execution of each project requires the correct strategy. Effort must be placed on scheduling appropriate resources from both the client and read more

Industries We Serve

Automated Systems

We understand the approach required for automated systems and information systems. For new systems we will work with your supplier, making as much use of read more

Industries We Serve

CFR 21 Part 11

The area of CFR 21 Part 11 regulation has been highly discussed and debated since being made effective in August 1997. The FDA is currently read more

Industries We Serve

Commissioning and Qualification

We serve clients in the various industries of medical devices and pharmaceuticals with products from parenterals, biologics, solid dosage, to Class I through Class III read more