Accreditation
We recognize that timely delivery and competitive pricing are crucial to the success of your project. However, we never compromise on quality to meet these goals. Instead, we’ve built a robust quality system that ensures full regulatory compliance while maintaining operational efficiency.
Our accreditations, certifications, and licenses demonstrate our dedication to meeting the highest industry standards. These credentials reflect our commitment to delivering services you can trust—services that protect product integrity, ensure patient safety, and support your path to market.
Below, you’ll find the regulatory frameworks and quality standards that govern our operations and validate our capabilities as your CRDMO partner.
FDA Registered Facility
As an FDA-registered facility, our quality system we established with strict adherence to the FDA regulatory requirements, such as 21 CFR Part 11, Part 211, Part 600, and QSR 820.
DEA Licensed Facility
Synergy Bioscience holds a license to test controlled substances (Class I through Class V). The license is current and issued by the Drug Enforcement Administration (DEA).
ISO 17025 Accredited
ISO 17025 accreditation ensures reliable test results that meet stringent regulatory requirements, reducing the risk of product recalls, compliance issues, and costly retesting. This accreditation provides enhanced credibility with regulatory bodies and customers worldwide, streamlining market access and demonstrating the company’s commitment to quality, safety, and technical competence in critical testing processes.
NELAP Accredited
NELAP accreditation establishes consistency in environmental testing methods across participating states, providing regulatory acceptance and enhanced credibility that eliminates the need for multiple state certifications while ensuring high-quality, reliable data. This nationally recognized program benefits environmental laboratories by increasing confidence in analytical data used for environmental compliance and pollution prevention, while streamlining operations through standardized quality management practices and fostering greater marketability across jurisdictions.
ISO 10993 Certified
ISO 10993 provides a comprehensive, internationally recognized framework for evaluating the biological safety of medical devices through risk-based assessment, ensuring that devices are safe for patient contact while minimizing unnecessary animal testing and accelerating regulatory approval processes. The standard encompasses a wide range of biological endpoints, including cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, and hemocompatibility testing, with specific guidance tailored to different device categories based on contact type, duration, and clinical use.
CLIA (Clinical Laboratory Improvement Amendments) is a mandatory federal regulation in the United States that establishes baseline requirements for all clinical laboratory testing performed on humans and supports clinical trials. Laboratories must obtain CLIA certification before accepting human specimens for testing.
AOAC Accredited Laboratory
AOAC accreditation ensures laboratories use scientifically validated testing methods that meet the highest international standards for accuracy and reliability, helping pharmaceutical, food, dietary supplement, and cannabis companies demonstrate regulatory compliance, reduce contamination risks, and build consumer trust through transparent quality assurance. The scope encompasses comprehensive chemical and microbiological analyses for products intended for human consumption, including foods, pharmaceuticals, dietary supplements, cannabis, environmental samples, ingredients, in-process samples, and final products, with specific criteria and guidelines tailored to each industry segment.