I will nutritional product design expert

I am specialized in creating 510(k) dossiers in compliance with FDA Regulations and submitting them to the FDA. Additionally, I prepare or review relevant regulatory documentation and provide regulatory affairs services for medical devices, food, drugs, and cosmetics for companies seeking assistance. With many years of experience

I will:

• Perform facility registration and device listing
• Obtain DUNS/UFI registration number with the FDA
• Create 510(k) documentation and submit it to the FDA, including reviewer follow-up until approval
• Register medical devices with the GUDID
• Obtain NDC codes; registered drug establishments must list each drug they distribute in the US, and each listed drug is assigned a National Drug Code (NDC).
• Assist with FDA reporting, such as vigilance and incident reporting
• Assist with pre-submissions to the FDA.