Audit-Ready.
Every Single Day.

Transparency is the foundation of trust. We maintain active registrations and licenses to ensure your product testing meets all federal and state requirements.

• FDA Registration:
  FEI 3032587727
• ISO/IEC 17025:2017 Accredited:
  Certificate #77504 (Biological Testing: USP <61>, <62>, <71>, <85>)
• cGMP Compliant:
  strictly adhering to 21 CFR Parts 210/211

In the modern regulatory landscape, data integrity is paramount. We have invested in a validated Laboratory Information Management System (LIMS) and Enterprise Content Management (ECM) architecture that ensures your data is ALCOA+ compliant.

Our Systems Feature:

• 21 CFR Part 11 Compliance:
  Validated functionality for electronic records and signatures.
• Audit Trails:
  Computer-generated, time-stamped audit trails that track every action and modification.
• Security:
  strict, role-based access controls to prevent unauthorized access or alteration.
• Oversight:
  Periodic review of audit trails by our Quality Unit to ensure continuous compliance.

We believe in defining responsibilities before the first sample arrives. We have a streamlined process for establishing Quality Agreements and Confidentiality Agreements (CDAs/NDAs) at the very start of our partnership.

Our Promise:

We don't let red tape slow down science. Our Quality Unit works directly with your team to finalize agreements quickly, ensuring you remain compliant without missing your testing window.

We conduct our work with the highest standards of ethical responsibility. We recognize that behind every data point is a patient.

• Confidentiality:
  Your proprietary information is safeguarded and accessed only by authorized personnel for legitimate business purposes.
• Ethics:
  We require honesty, transparency, and accountability in all business activities. We strictly prohibit any action that compromises data integrity or public trust.
• Reporting:
  We maintain an open culture where concerns can be reported and addressed promptly.