Guard Your Proprietary Product Data with a Master File Submission

Guard Your Proprietary Product Data with a Master File Submission

Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or National Medical Products Association (NMPA) in China.

Metti FDA prepares and submits Drug, Medical Device, and Veterinary Master Files to 18 regulatory agencies worldwide.


What is a Master File?

As part of certain drug and medical device applications to regulatory agencies, a company may need to reference data from another product used in the manufacture of their own, such as packaging, ingredients, or accessories.  The owner of this data may choose to submit a Master File to disclose proprietary or confidential information concerning their product to a regulatory agency without providing it to parties that need to reference it.

Many agencies require submission of Master Files in electronic common technical document (eCTD) format.

Veterinary Master Files (VMFs) & Other Common Types of Master Files

Metti FDA Submits Master Files to the Following Agencies

Health Canada

U.S. Food and Drug Administration (FDA)

United Kingdom

Chinese National Medical Products Administration (NMPA)

European Union

Other locations Metti FDA can help submit to:

Australia · Bahrain · Bosnia and Herzegovina · Hungary · Jordan · Kuwait · Oman · Qatar · Saudi Arabia · South Africa · Switzerland · United Arab Emirates · WHO (World Health Organization)