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.