Creganna-Tactx Medical and Boston Biomedical Associates Form Partnership

Creganna-Tactx Medical and Boston Biomedical Associates (BBA) have formed a joint venture partnership intended to ease some of the regulatory burdens faced by their medical device clients.

Under the agreement, 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 and California facilities and staffed by regulatory and quality professionals who will have a dedicated focus on Creganna-Tactx Medical customers.

Creganna-Tactx Medical provides outsourced manufacturing 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 that provides consulting services to companies developing and commercializing medical devices.

Under the partnership agreement and by leveraging BBA’s extensive experience, expertise and consulting services, Creganna-Tactx Medical now will provide a broad range of quality and regulatory support to its customers, company officials said. Services will 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.

“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,” said Helen Ryan, Creganna-Tactx Medical CEO. “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 has an excellent track record in this specialized field and are a proven partner in the provision of this new service to our customers.”

According to Lauren Baker, PhD, president and owner of BBA, the joint venture will allow her firm to introduce its methodologies 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 U.S. and internationally,” Baker said.

The services to be provided under the joint venture partnership will be available immediately to Creganna-Tactx Medical customers.

Headquartered in Galway, Ireland, Creganna-Tactx Medical employs 1,000 people worldwide and has design and manufacturing operations in the California, Minnesota, Massachusetts, Singapore and Korea.

Boston Biomedical Associates helps to guide emerging and established medical device companies through the regulatory approval process, as well as post-market activities (e.g., medical device reporting and vigilance reporting). This firm’s 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 works in the development, execution and successful completion of clinical trials leading to FDA approval/clearance for medical devices and biomedical technologies. The company has offices in Northborough, Mass. and in the Bay Area of California.