Manufacturers Assistance and Technical Training Branch (MATTB)

Email: Industry.Biologics@fda.hhs.gov
Phone: 240-402-8020 or 1-800-835-4709

After hours (after 4:30 pm EST weekdays, all day on weekends, and federal holidays)
FDA Emergency Call Center, Phone: 866-300-4374 or 301-796-8240


What The MATTB Does
CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide timely, accurate and useful information to stakeholders.


How MATTB Can Help You
If you have a question about a biologics topic, MATTP may be able to help you. They try to respond to email within 5 business days.

If your inquiry is related to a regulatory submission that has been received by CBER, questions should be directed to the Regulatory Project Manager (RPM) assigned to that submission.


SoftwareCPR® can often provide timely advice that can optimize our clients’ interactions with FDA.  If you would like to discuss your question with one of our partners, please give us a call at +1-781-721-2921 or leave a message below:

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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

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15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.