Certifications

ISO-13485:2016 Certified

Being ISO-13485:2016 Certified allows our customers to gain confidence that we have been audited by a third party and that we follow all the applicable regulations under the scope of our ISO certification. To download our certificate please fill out the form by clicking below.

Download the Certificate

FDA Registrations

FDA REGISTRATION NUMBER - 3012351224

LAUNCHWORKS MANUFACTURING LAB
123 Brimbal Ave
Beverly, MA 01915
UNITED STATES

FDA REGISTRATION NUMBER - 3018301242

LAUNCHWORKS CDMO
11000 Boulevard Parkway
Anjou, Quebec H1J 1R6
CANADA

cGMP Facility

LaunchWorks adheres to the Current Good Manufacturing Practice (cGMP) regulations enforced by the FDA. These regulations assure proper design, monitoring, and control of manufacturing processes at all of our facilities.

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ISO 13485:2016 Certificate Download

Please fill in the brief form below to download a PDF of the LaunchWorks Manufacturing Labs’ ISO 13485:2016 certificate.

Please contact our General Manager or QA Department with specific questions about our certification.

Advance your life sciences products for optimized results, no matter the production stage. As a full-service ISO-13485:2016 and FDA registered certified contract manufacturer, LaunchWorks CDMO’s mission is to help you focus on your science.

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