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.
Anneliese - Quality Manager: experienced in Master Batch Record (MBR) and Executed Batch Record (EBR) reviews and auditing.
Experienced in managing Quality Systems documentation management: Policies, SOPs, forms, templates and guidelines with formatting and structure to fit your needs and maintain consistency in quality compliance.
What we offer
Experienced in auditing 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..... We have a passion for the patient, quality and compliance in the industry. We have handled life-saving products in a combination of medical therapies for neonates and the newest technology: Antibody-Drug Conjugate, Cell & Gene Therapy and several technologies that improve patients health and life. We look forward to a partnership of empowering solutions that provide compliant platforms to build success.
Let's work together in building a strategy that meets your 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 Compliance Consultants, Inc. , 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 strategies. 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 fully 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.