4 Key Factors to Consider When Choosing an Effective Regulatory Outsourcing Partner

New White Paper Shares Practical Advice to help Pharmaceutical and Biotech Companies Determine the Why, What and How of Selecting a Successful Regulatory Partner

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Cardinal Health

Aug 28, 2014, 09:00 ET

DUBLIN, Ohio, Aug. 28, 2014 /PRNewswire/ -- A decline in revenues from approved products and rising competition in generics are adding pressure to pharmaceutical, biotechnology and medical device companies and their internal resources. Company resources continue to shrink and approval processes and postapproval requirements have become more complex. This has led companies to look for additional support and expertise for clearing regulatory hurdles to commercialization and for keeping approved products on the market.

While it's often tempting for pharmaceutical companies to keep development and regulatory processes in-house, outsourcing provides a variety of solutions. Tapping into outside expertise uniquely positions organizations to have a competitive advantage to guide products to approval and meet postapproval requirements. Furthermore, it saves valuable time and allows internal teams to focus on other pipeline projects. When considering an outsourcing partner, companies need to make sure the partner they choose is a good fit for their business, needs and budgets.

The Cardinal Health Regulatory Sciences team recently published a white paper that explores the four key factors that help pharmaceutical and biotech companies understand the why, what and how of selecting a successful regulatory partner.

Knowing when to consider outsourcing regulatory services – for example, when you need to augment the expertise of your current staff; expand capacity; overcome unique regulatory challenges; or manage costs by only using outsourced regulatory expertise on an as-needed basis.
What functions are best outsourced – theoretically, the entire preapproval and postapproval technical writing process can be outsourced. But more practically, it makes the most sense to outsource those regulatory approval functions that require a high level of expertise or are resource intensive.
How pharmaceutical and biotech companies can benefit – whether it's immediate access to highly experienced consultants or additional capacity to address unforeseen challenges, outsourcing regulatory consultation services can offer a broad array of benefits.
How to select the right partner for your needs – it's important to start your search for an outsourcing partner early, and to make sure you're asking the right questions to get the answers you need to help you make the best choice.

To learn more about each of these core facets of selecting the best regulatory partner, download this white paper, 'The outsourcing playbook: How to make regulatory outsourcing effective for the pharmaceutical, biotechnology, and medical device industries,' or visit Cardinal Health Regulatory Sciences' web site, here.

Cardinal Health Regulatory Sciences provides a wide range of consulting services required to obtain marketing approval and keep marketing licenses for drugs, biologics and medical devices around the world. This team helps biotechnology, pharmaceutical and medical device clients increase the financial returns on their research investments through the design and implementation of efficient global preapproval and postapproval scientific and regulatory strategies.

About Cardinal Health, Inc.
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $91 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers, clinical laboratories and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality. Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products and services to more than 100,000 locations each day and is also the industry-leading direct-to-home medical supplies distributor. The company is a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company operates the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #22 on the Fortune 500, Cardinal Health employs 34,000 people worldwide. More information about the company may be found at www.cardinalhealth.com and @CardinalHealth on Twitter.