Quality and Regulatory Consulting Service

Let us help bring your company to the next level of compliance and regulatory adherence! Whether it is ISO, FDA, or local regulations, we are here to help!

Our Approach

Collaborative

We believe in the power of collaboration to foster a company of quality. As an extension of your team, we aim to immerse ourselves in your vision and goals. We will work closely with you to address any regulatory concerns and help plan for the future.

Detail Orientated

We pride ourselves in a detailed orientated approach to ensure that your company is audit ready. Whether that is a deep documentation review, a comprehensive mock audit, or establishing a fully compliant quality management system. We are here to bring confidence to your quality and regulatory compliance.

FAQ

  • We'll start with a free consultation to discuss your regulatory wants and needs.

  • Pricing is based on both the project's scope and your desired timeline. Whether it is a day audit or multiple month QMS establishment project, we will be there to assist.

  • Whether it is ISO requirements, FDA regulations, CAP or CLIA, we aim to bring comfort and compliance expertise to your company. Our specialties are:

    • ISO 9001, 13485, 14001, 14155, and 17025

    • FDA 21 CFR

    • OSHA Regulations

    • PMA and 510K submissions

    • CAP and CLIA

    • HIPAA

    • Test Validation

    • NCE & CAPA Management

    • Risk Assessments

    • Project Management

Inquiries