Creganna-Tactx Medical and BBA in
partnership to provide medical device consulting services
22 Feb 2011
Galway-based Creganna-Tactx Medical and Boston Biomedical Associates (BBA)
have formed 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 provides 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.
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
The services to be provided under the joint venture partnership
will be available immediately to Creganna-Tactx Medical customers.