Regulatory

Ethox International’s facilities are FDA registered (device and drug) and are certified to the following European standards through the British Standards Institute (BSI), the senior European Notified Body:

ISO-13485(2003) – Medical Devices – Quality Management Systems
ISO-11135/EN-550 – Ethylene Oxide
ISO-11134/EN-554 – Steam Sterilization

Our customers benefit from over 40 years of excellence in quality and regulatory compliance. In addition, all Ethox International processes are conducted in accordance with applicable US device/drug good manufacturing practices as well as, when requested, good lab practices.

Our corporate level quality manual, standard operating procedures and facility based work instructions and test methods are key components of our corporate quality system. Routine internal auditing, metrics development and trending as well as management review of Ethox International’s quality system, ensure accuracy and strict adherence to FDA, ISO and other pertinent requirements. This, in turn, enables us to continue to deliver quality products and services to our customers.

Our small-animal vivarium and animal care program is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). This organization is a worldwide private nonprofit group that is dedicated to the promotion of humane treatment of animals in science, through a voluntary accreditation program. AAALAC accreditation, which we have held since 1986, is a symbol of quality animal care within the scientific community. An AAALAC team performs a site visit every three years to assess the animal care program and to provide assistance with maintaining a quality program. In addition maintaining AAALAC accreditation, our vivarium program is inspected annually by the US Department of Agriculture. We are a member of the American Association for Laboratory Animal Science.

Regulations & Standards
Ethox International operates in accordance with pertinent regulations and standards of the following organizations:

• Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)
• American Association for Laboratory Animal Science (AALAS)
• Association for the Advancement of Medical Instrumentation (AAMI)
• New York Department of Environmental Conservation (NYDEC)
• New York Department of Health (NYDOH)
• United States Drug Enforcement Agency (USDEA)
• United States Department of Transportation (USDOT)
• United States Environmental Protection Agency (USEPA)
• United Stated Food and Drug Administration (USFDA)
• Occupational Safety and Health Administration (OSHA)
• United Stated Department Agriculture (USDA)
• Pharmacopoeial Testing:
• United States (USP)
• European (EP)
• Japanese (JP) 
• Danish Medicines Authority

Regulatory Affairs and Related Services
Ethox International develops and maintains the following records, documents and services as a routine part of operation:

• Device Master Records (DMR)
• Device History Records (DHR)
• 510(k), IDE, PMA consultation and preparation assistance
• Minimum 5-year record retention
• Lot certification/documentation packets
• Routine documentation releases
• Technical File development and assistance