Our company is your best source for professional, value driven service. Established in 2004, we have decades of collective and comprehensive knowledge and experience. This means that we are able to provide the most value and innovation per your dollar spent. Our professional consultants have the compliance answers you need when you need them.
Staff certifications and qualifications are available on request and include ASQ's Certified Biomedical Auditor (ISO 13485) and Certified Software Quality Engineer, RAC, Lead Auditor (ISO 9001) and much more!
About Us
Recent Projects:
- Quality Assurance for Biostatistics department of a large pharmaceutical company
- Facilitated the first Managment Review for an ISO 9000 certified software developer
- Software Quality Consultant for an IVD manufacturer. Process improvement and validation planning and execution for over 50 pieces of quality system and manufacturing software
- Assessment of a data management service provider
- Audit of several clinical investigation sites for possible inclusion in specialty studies
- Creation of a quality system for a small on-line training vendor new to regulated customers
Customer List is available on request.
