Compliance

Seventh Wave Laboratories performs discovery stage work as a non GLP service offering and we also support regulated studies in compliance with the GLP regulations listed below.

Our goal is to provide advice, analysis, and answers that are aligned with both our client’s needs and also with the regulator’s expectations. Seventh Wave SOPs and quality systems are designed to provide the appropriate regulatory rigor for each phase of development. A partial list of the regulations which we comply with are here:

  • 21 CFR 11 and 58
  • 40 CFR 160 and 792
  • OECD C(97)186
  • JMHLW Ordinance 21
  • JMAFF 59 NohSan No. 3850

Clinical Studies (GCP)

Portions of clinical studies conducted at Seventh Wave (typically limited the PK/PD evaluation) are performed in compliance with applicable sections of:

  • 21 CFR 11 and 312
  • ICH E6

Bioequivalence Studies

Portions of bioequivalence studies conducted at Seventh Wave (typically data evaluation) are performed in compliance with applicable sections of:

  • 21 CFR 210, 211 and 820

Veterinary Clinical Studies
Portions of veterinary clinical studies conducted at Seventh Wave (typically microscopic pathology evaluation) are performed in compliance with applicable sections of:

  • VICH GL9

Animal Care

Seventh Wave operates in compliance with all USDA regulations and our in-life facility is fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).
www.aaalac.org

Registrations

Drug Enforcement Agency (DEA)
Seventh Wave is currently licensed by the U.S. Drug Enforcement Agency.
The registration number is confidential.
www.dea.gov
www.dhss.mo.gov/bndd

U.S. Environmental Protection Agency (EPA)
Registration number: MOR000516344
www.epa.gov

Missouri Department of Natural Resources (DNR)
Registration number: 040209
www.dnr.mo.gov