Welcome to our website
Robert M. Satterfield, Principal: 'Bob' has 35 years of industry experience in pharmaceutical small & large molecule, biologics, medical device and combination products. Educated in chemistry with industry service in Quality Control, Regulatory Affairs, and Quality Assurance.
Experienced auditor from raw material suppliers, commodity brokers/molders, medical devices, solid oral dosage and injectibles. Direct interaction with regulatory bodies: US FDA, Health Canada, COFEPRIS, TGA, ANVISA, MHRA, HPRA, EMEA, PMDA..... Mr. Satterfield has a passion for the patient and the quality science of the industry. He has worked on life saving combination of medical therapies for neonates and the newest technology: Antibody-Drug Conjugate for cancer treatment. We look forward to a partnership of empowering solutions that provide compliant platform to build success.
Let's work together in building a strategy that meets requirements and provides right size solutions for the future of your company
Experience You Can Count On
Our service includes a comprehensive consultation to help identify gaps and opportunities, an assessment report that includes a map to the risks in relation to specific regulations of marketed target countries.
Based on Risk Assessments and complexity of Quality Designs a project plan can be developed with timelines and milestones to meet your business needs. We also offer a suite of Qual-A-Carte quality products that will help you get there quickly and smoothly. That’s how we ensure your success.
Mission
Quality In Compliance, QAINC provides solutions to meet the increasing complex regulatory landscape. At QAINC, we’ve experienced first-hand what it takes to build a successful quality management system to meet your compliance strategy. Together, We build Solutions that support growth, sustainability and profitable improvement opportunities.
Team & Partnership
No opportunity is too small or too big. We have the tools and skill set you need. If you are a virtual or a full staffed company, together we can find the right solution(s). With this empowerment, the footprint of quality compliance remains for Success. "Effective compliance management is seen as a source of competitive advantage, with compliance officers required to demonstrate the value of their function in the organization." - A Bold Future for Life Science Regulation, Deloitte Centre for Health Solutions, 11/18.
Experience you can count on.
No opportunity is too small or too big. We have the tools and skill set you need. If you are a virtual or a full staffed company, together we can find the right solution(s). With this empowerment, the footprint of quality compliance remains for Success.
"Effective compliance management is seen as a source of competitive advantage,
with compliance officers required to demonstrate the value of their function in the
organization."
- A Bold Future for Life Science Regulation, Deloitte Centre
for Health Solutions, 11/18.