GALWAY, Ireland & NORTHBOROUGH, Mass.--(BUSINESS WIRE)--Creganna-Tactx Medical and Boston Biomedical Associates (BBA) today announced a joint venture partnership under which Creganna-Tactx Medical customers will have dedicated access to clinical, regulatory and quality expertise and consulting services. The joint venture company will be co-located at BBA’s Massachusetts & California facilities and staffed by experienced regulatory and quality professionals who will have a dedicated focus on Creganna-Tactx Medical customers.
Creganna-Tactx Medical is a leading global provider of outsourced solutions to medical device manufacturers. The company specializes in design and manufacturing of delivery devices for minimally and less invasive therapies. Boston Biomedical Associates is a clinical research and regulatory/quality affairs organization who provide consulting services to companies developing and commercializing medical devices. The company also has extensive expertise in minimally and less invasive therapeutic products.
Under the partnership agreement and by leveraging BBA’s extensive experience, expertise and consulting services, Creganna-Tactx Medical will now provide a broad range of quality and regulatory support to its customers. These include development of appropriate regulatory and clinical strategies, regulatory submission development and liaison services, management of clinical trials and associated consulting services to achieve successful product approval and commercialization support. The service will be provided for a global market to include worldwide approval pathways and international regulatory support.
Commenting on the announcement, Creganna-Tactx Medical CEO, Helen Ryan said: “The new services to be provided under this joint venture partnership perfectly complement our current service portfolio and respond to the evolving requirements of our customers. We have designed and manufactured complete products on behalf of our customers for many years; therefore managing the regulatory and quality process on their behalf is a natural progression. BBA have an excellent track record in this specialized field and are a proven partner in the provision of this new service to our customers.”
Lauren Baker, PhD, President and owner of BBA said: “BBA is looking forward to expanding the customer base for which we provide our proven regulatory, quality and clinical services. The joint venture with Creganna-Tactx Medical will allow us to introduce our methodologies and proven approach in an evolving market where outsourcing companies, in partnership with their customers, are assuming legal responsibility for product manufacture. Creganna-Tactx Medical’s design and manufacturing capabilities, coupled with our regulatory, quality and clinical expertise will provide Creganna-Tactx Medical customers with a proven pathway for product approval and commercialization support in the US and internationally.”
The services to be provided under the joint venture partnership will be available immediately to Creganna-Tactx Medical customers.
About Creganna-Tactx Medical
Creganna-Tactx Medical is a leading supplier of products, technologies and services to medical device and lifescience companies worldwide. Creganna-Tactx Medical specialize in the design and manufacture of minimally & less invasive delivery and access devices for a range of therapies. Headquartered in Galway, Ireland, Creganna-Tactx Medical employs 1,000 people worldwide and has design and manufacturing operations in the US (CA, MN & MA) and Asia (Singapore & Korea.)
For more information visit: www.cregannatactx.com
About Boston Biomedical Associates
Boston Biomedical Associates is a leading clinical, regulatory and quality consulting firm serving emerging and established medical device companies. BBA has extensive expertise in guiding companies through the regulatory approval process, as well as post market activities (e.g. MDR, vigilance reporting). This expertise includes supporting domestic and international regulatory approvals, customizing Quality Systems to meet the needs of the regulations as well as the client. BBA also has a proven track record in the development, execution and successful completion of clinical trials leading to FDA approval/clearance for medical devices and biomedical technologies. BBA’s focus is to deliver services to bring new technologies to market, on time, on budget, and with greater efficiency across a broad range of products and therapeutic areas. Boston Biomedical Associates has offices in Northborough, MA and the Bay Area in CA.
For more information visit: www.boston-biomedical.com