Cardinal Health Acquires Beckloff Associates, Consultants to Pharmas and Biotechs
17 February 2004
Cardinal Health, the leading provider of products and services supporting the health care industry, today announced it has acquired Beckloff Associates, Inc. to help its biotechnology, pharmaceutical and medical service customers worldwide bring products to market more rapidly. Terms were undisclosed.
The 28-year-old consultancy firm, based in Kansas City, works closely with client companies to design and implement global regulatory strategies required to obtain marketing approval for drugs, biologics and medical devices in the U.S., Canadian, and European markets. The company provides extensive expertise in the areas of strategic regulatory and product development planning, total project management and regulatory authority interaction. In addition, the company provides regulatory documentation support, including preparation of investigational new drug applications (INDs), new drug applications (NDAs), 505(b)(2) applications, common technical documents (CTDs), abbreviated new drug applications (ANDAs), drug master files (DMFs), and all forms of electronic submissions.
The firm provides a wide range of consulting services in the area of chemistry, manufacturing, and control (CMC). This expertise includes regulatory specification development, stability study design, technology transfer, process evaluation, formulation optimization, analytical methods evaluation, development report preparation and process validation design and reporting, as well as preparation of all CMC related regulatory documentation. The firm also assists clients with the establishment and implementation of full current good manufacturing practices (cGMP) compliance and pre-approval readiness programs and Part 11 reviews.
"As the market for new pharmaceutical and biotechnology-related products continues to grow, companies require exceptional counsel to launch their products swiftly– and Beckloff Associates provides such consulting expertise," said Frank Leo, group president within the Pharmaceutical Technologies and Services business of Cardinal Health. "This move adds yet another strategic service to Cardinal Health’s portfolio, which now encompasses nearly all stages, from pre-clinical development to manufacturing, packaging, marketing, and distribution."
"The outlook has never been brighter for the scientific and regulatory expertise we offer," said Michael C. Beckloff, president of Beckloff Associates. "As the leading provider of products and services to the health care industry, Cardinal Health affords us the chance to assist many more companies as they navigate the regulatory path and accelerate the entry of their innovations to the marketplace."
Beckloff Associates was founded in 1976 to assist pharmaceutical, biotech, and medical-device companies with regulatory approvals for their products. Its consultants will add new expertise to the Life Science Products and Services group of Cardinal Health, with emphasis on helping customers increase the financial return on their research investments through the design and implementation of efficient scientific and regulatory strategies.
