Company Overview
At LaunchWorks, our people are our greatest asset.
We are a winning team of innovative, experienced, and knowledgeable contract manufacturing experts with a track record of turning complex life science ideas into high-quality products on-time and on-budget. We are committed to accelerating life science product commercialization by optimizing every step of the manufacturing process in order to create high-quality products for our customers that reach the market and the people that need it, safely and quickly.
Our operational competency has enabled us to maintain trustworthy and transparent relationships with our customers.
Our Quality Policy
As a Contract Design, Development, and Manufacturing Organization, LaunchWorks drives advancements in Life Science tools available to scientists, doctors, and patients. Launchworks develops and manufactures products consistently, exactly, and reliably to client specifications while meeting applicable quality and regulatory requirements.
Launchworks utilizes our unique change control system to facilitate rapid and compliant product updates for our clients, lowering their barriers to enter the market. By emphasizing continuous improvement, LaunchWorks ensures the effectiveness of its quality management system and regulatory compliance to meet or to exceed the objectives of our clients.
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.
FDA Registrations
FDA REGISTRATION NUMBER3012351224
LAUNCHWORKS MANUFACTURING LAB
123 Brimbal Ave
Beverly, MA 01915
UNITED STATES
FDA REGISTRATION NUMBER3018301242
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.
Partnerships
National Research Council of Canada
The NRC is Canada’s largest federal research and development organization. The NRC partners with Canadian industry to take research impacts from the lab to the marketplace, where people can experience the benefits. This market-driven focus delivers innovation faster, enhances people’s lives and addresses some of the world’s most pressing problems.
EVIK Diagnostic Innovations
Evik’s Single-Assay Beads are precise and durable spheres, each originating from a few microliters of liquid reagent mix. Evik helps assay developers solve the common challenge of assay reagent stability by incorporating reagents into stable lyophilized beads that are versatile for use in micro-fluidic cartridges.
Mercury Logistics
Mercury is the official LaunchWorks logistics partner, specializing in time and temperature sensitive supply chain management. Mercury creates customized shipping solutions and will proactively track every package, offering this and other solutions so you can focus on your business.
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