NWRS and CLIA WAIVERS

We specialize in CLIA waivers.

NWRS experience with the FDA and the CLIA waiver process has resulted in a proven record of success in obtaining CLIA waivers for our clients.

New World Regulatory Solutions will:

• Interact with the FDA
• Recommend device design that meets CLIA waiver requirements
• Create specialized labeling that meets CLIA requirements
• Develop protocols for CLIA waiver studies
• Negotiate FDA agreement on study design and protocols
• Conduct all CLIA waiver studies (Field and Laboratory)
• Analyze data
• Prepare and submit CLIA waiver application to the FDA
• Track the FDA review of your submission
• Address and solve FDA concerns