--- title: Certifications | LaunchWorks Contract Manufacturing Organization Lab description: 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. --- [Skip to content](https://www.launchworkscdmo.com/certifications#main-content) - [Customer Fulfillment Portal](https://launchworks.lp4fb.com/index.php?route=account/login) - [Contact Us](https://www.launchworkscdmo.com/contact-us) Close - Diagnostic Solutions - [Product Manufacturing Plan](https://www.launchworkscdmo.com/the-launchworks-process) - [Design & Development](https://www.launchworkscdmo.com/design-and-development) - [Manufacturing](https://www.launchworkscdmo.com/manufacturing) - [Fulfillment & Storage](https://www.launchworkscdmo.com/fulfillment-and-storage) - Resources - [Blog](https://www.launchworkscdmo.com/blog) - [Case Studies](https://www.launchworkscdmo.com/case-studies) - Company - [Our Mission](https://www.launchworkscdmo.com/about) - [Certifications](https://www.launchworkscdmo.com/certifications) - [Partnerships](https://www.launchworkscdmo.com/partnerships) - [Careers](https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=17f3997b-cf29-4fb6-870e-662bde99b8dd&ccId=9200188977426_2&lang=en_US) - [Contact](https://www.launchworkscdmo.com/contact-us) SEARCH [![Get Started](https://no-cache.hubspot.com/cta/default/2359995/aaac3be2-73d0-4b11-b3d8-553a63b93d45.png)](https://cta-redirect.hubspot.com/cta/redirect/2359995/aaac3be2-73d0-4b11-b3d8-553a63b93d45) [![LaunchWorks Manufacturing Lab](https://www.launchworkscdmo.com/hs-fs/hubfs/LaunchWorks%20logo%20and%20tag_RGB.png?width=400&height=77&name=LaunchWorks%20logo%20and%20tag_RGB.png)![LaunchWorks-logo-WHITE_w-tag](https://www.launchworkscdmo.com/hubfs/Logo/LaunchWorks-logo-WHITE_w-tag.svg)](https://www.launchworkscdmo.com?hsLang=en) - Diagnostic Solutions - [Product Manufacturing Plan](https://www.launchworkscdmo.com/the-launchworks-process) - [Design & Development](https://www.launchworkscdmo.com/design-and-development) - [Manufacturing](https://www.launchworkscdmo.com/manufacturing) - [Fulfillment & Storage](https://www.launchworkscdmo.com/fulfillment-and-storage) - Resources - [Blog](https://www.launchworkscdmo.com/blog) - [Case Studies](https://www.launchworkscdmo.com/case-studies) - Company - [Our Mission](https://www.launchworkscdmo.com/about) - [Certifications](https://www.launchworkscdmo.com/certifications) - [Partnerships](https://www.launchworkscdmo.com/partnerships) - [Careers](https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=17f3997b-cf29-4fb6-870e-662bde99b8dd&ccId=9200188977426_2&lang=en_US) - [Contact](https://www.launchworkscdmo.com/contact-us) [![Get Started](https://no-cache.hubspot.com/cta/default/2359995/aaac3be2-73d0-4b11-b3d8-553a63b93d45.png)](https://cta-redirect.hubspot.com/cta/redirect/2359995/aaac3be2-73d0-4b11-b3d8-553a63b93d45) Search Suggestions ![banner-logo--left](https://www.launchworkscdmo.com/hubfs/Site_Assets/Banners/banner-logo--left.svg) # Certifications ![ISO13485-Featured-Img](https://www.launchworkscdmo.com/hs-fs/hubfs/images/ISO13485-Featured-Img.png?width=658&height=392&name=ISO13485-Featured-Img.png "ISO13485-Featured-Img") ### 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](https://www.launchworkscdmo.com/certifications#download) --- ![FDA-Registered-Featured-Img](https://www.launchworkscdmo.com/hs-fs/hubfs/images/FDA-Registered-Featured-Img.png?width=658&height=392&name=FDA-Registered-Featured-Img.png "FDA-Registered-Featured-Img") ### FDA Registrations ##### FDA REGISTRATION NUMBER - [3012351224](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=209951) LAUNCHWORKS MANUFACTURING LAB 123 Brimbal Ave Beverly, MA 01915 UNITED STATES ##### FDA REGISTRATION NUMBER - [3018301242](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=290428) LAUNCHWORKS CDMO 11000 Boulevard Parkway Anjou, Quebec H1J 1R6 CANADA --- ![cGMP-Img](https://www.launchworkscdmo.com/hs-fs/hubfs/images/cGMP-Img.png?width=658&height=392&name=cGMP-Img.png "cGMP-Img") ### 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. [Learn More](https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations) ### 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. [![LaunchWorks-logo-WHITE_w-tag](https://2359995.fs1.hubspotusercontent-na1.net/hubfs/2359995/Logo/LaunchWorks-logo-WHITE_w-tag.svg)](https://www.launchworkscdmo.com?hsLang=en) 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. All rights reserved - [Terms and Conditions](https://www.launchworkscdmo.com/launchworks-terms-and-conditions) - [Customer Fulfillment Portal](https://launchworks.lp4fb.com/index.php?route=account/login) - [Contact](https://www.launchworkscdmo.com/contact-us) ```json { "@context" : "https://schema.org", "@type" : "Organization", "address" : { "@type" : "PostalAddress", "addressCountry" : "USA", "addressLocality" : "Beverly", "addressRegion" : "MA", "postalCode" : "01915", "streetAddress" : "123 Brimbal Avenue" }, "knowsLanguage" : "en", "logo" : { "@type" : "ImageObject", "url" : "https://cdn2.hubspot.net/hubfs/2359995/LaunchWorks%20logo%20and%20tag_RGB.png" }, "name" : "LaunchWorks CDMO", "url" : "https://www.launchworkscdmo.com/certifications" } ```