Request Access to a DMF Letter of Authorization (LOA) or a CTS RSF

About your request

Tell us how we can support you

Are you requesting a DMF Letter of Authorization, or a Regulatory Support File?*

DMF Letter of Authorization (LoA)

Regulatory Support File (RSF)

Both

Please select the appropriate region(s).*

US, FDA DMF

Japan, PMDA DMF

Canada, Health Canada DMF

Other region

Other (please specify)

Product use

Thermo Fisher Scientific’s products are considered raw or ancillary materials for further manufacturing applications. They are not intended for direct administration into humans.

Please confirm the use of the Thermo Fisher Scientific product requested is not for direct administration.*

Yes, the product will be directly administered to humans.

No, the product is not for direct administration into humans.

About your Regulatory Filing

Company Name*

Application Number (e.g. IND Number)*

Application Filing Date (please input date MM/DD/YY)*

Application Title*

Application Phase*

Primary Investigator Name(s)*

National Clinical Trial (NCT) identifier*

About our product

For which Thermo Fisher Scientific product do you need support?

Thermo Fisher Scientific SKU:*

Product Name:*

About you

Please provide the following information for the Letter of Authorization and/or RSF.

First name*

Last name*

Telephone*

Email*

Institution type*

Street address*

City*

State/Province*

Postal Code/Zip*

Country/Region*

Requestor Details

Name of person completing this form:*

Email address of person completing this form:*

Acknowledgement

By submitting this form to Thermo Fisher Scientific, I am requesting a DMF Letter of Authorization and/or Regulatory Support File. For a Regulatory Support File, I understand this will only be provided after signing a confidentiality disclosure agreement.