Valuable Help in Planning Your Study

The Surpass team has proven experience conducting translational preclinical research across a vast number of disciplines. We provide valuable support every step along the study process, and can provide insightful advice on conducting a successful study the first time.

To assist you in these efforts, we have compiled a few important resources:

US Regulations and Helpful Regulatory Sites

  • Good Laboratory Practice (GLP) Regulations 21 CFR Part 58
  • Food Drug and Cosmetic Act
  • Electronic Records Electronic Signatures 21 CFR Part 11
  • Animal Welfare Act and Regulations 9 CFR Parts 1-4
  • Quality Systems (QS) Regulations/Medical Device Good Manufacturing Practices
  • FDA Pre-Market Notification Section 510(k)

FDA Guidance Documents

  • FDA ODE Guidance Documents
  • CDRH's List of Proposed Guidance Documents for Release and Review in 2021
  • Search the FDA website for a guidance document you need

OUS Regulations and Helpful Regulatory Sites

  • OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring
  • Japan's Pharmaceuticals and Medical Devices Agency (PMDA)
  • European Commission - Public Health
  • Health Canada's Medical Device Regulations

Useful Articles

  • Medical Device Innovation Initiative White Paper by CDRH

Are you a current client of Surpass? Access additional valuable resources for model selection and study planning through your MySurpass portal.