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THE WHAT AND WHY OF REGULATORY OUTSOURCING Today’s evolving healthcare landscape poses unprecedented challenges to biopharmaceutical companies. Consolidation, budget cuts, restructuring, globalization—how does a company compete effectively and increase market share? By focusing on core competencies. Outsourcing began in a meaningful way some 25 years ago as biopharmaceutical companies sought new ways to drive efficiency and reduce cost. More functions are being outsourced today, in fact, than anyone would have imagined even 10 years ago. The regulatory maintenance of launched products is no exception, with biopharmaceutical companies carefully designing outsourcing strategies that allow them to focus on developing and differentiating their pipeline with pricing, reimbursement and access strategies that drive commercial success.

Spending on regulatory outsourcing among

“In terms of what activities our clients

biopharmaceutical companies grew 167 percent

think about outsourcing first,” says Scott

from 2007 to 2010, according to a Tufts Center

Bergeron, Vice President, Customer

for the Study of Drug Development report.1 And

Strategy at PAREXEL, “it tends to

why wouldn’t it? These routine maintenance lifecycle activities such as label or manufacturing

incorporate anything that’s tactical

changes and renewals are low risk but critical to a

operations, movement of information,

company’s bottom line. Research and development

documentation management, or document

are the lifeblood of a biopharmaceutical company,

flow, due to the fact that they are low risk

but regulatory compliance, while perhaps less

activities, yet incredibly important.”

strategic, is vital to earnings and growth.

TRUSTED PARTNERSHIPS BASED ON DOTTED I’S AND CROSSED T’S Submitting regulatory paperwork that is accurate and meets submission timelines is critical. And the more products there are to maintain, the more markets there are that a company must keep abreast of and the more sense it makes to outsource. Chet Shemanski, Senior Director, Partnerships

departments to keep that product up-to-date from

and Solution Strategy at PAREXEL, poses the

a compliance perspective once it launches. As

decision to outsource in the form of a question:

regulatory budgets shrink and workloads increase,

“With tightened budgets prompting organizational

it’s not unheard of for regulatory departments to

prioritization, would you want to employ 50 people

demand as much as 25 percent of a company’s

in your company to keep products registered or to

total operational budget. Not every company has –

focus on regulatory strategies for developing and

or wants to invest - the resources to hire additional

marketing newer products under patent?”

staff to handle the ever-adapting demands of the regulatory process while not poaching from the

It takes years to bring a new product to market

resources needed for R&D.

and thousands of hours invested by whole

1 “Drug Sponsors’ Regulatory Experience Was Mixed During PDUFA IV,” Tufts Center for the Study of Drug Development, May/June 2012.

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THINK GLOBALLY, THRIVE LOCALLY Growth and profits depend on international market share and, in the biopharmaceutical industry, a broader level of local, on the ground expertise is needed now more than ever before. The markets of Brazil, China, India and Russia are highly coveted and come with their own set of rules. Even the European Union, which has one overseeing agency in the European Medicines Agency, can have 28 different interpretations of regulations for each of its member states. Efficiency in operation with appreciation of

regulations. Our resources on the ground know

culture and bureaucracy is a must, but can

that the dossier requires a wet signature instead

pose a significant challenge for growing

of a photocopy.” That kind of know-how can only

biopharmaceutical companies. PAREXEL’s

come with experience. Even the largest, most

Shemanski concurs, “It can take well over a year

well-funded companies can be overwhelmed

to get products up and out in new markets and

with a region’s culture and changing regulations.

that time can be all it takes for a company to lose

Outsourcing proves a worthy solution.

its advantage.” “We actually understand the challenges and The need for local, regional and national

implications of managing the regulatory

regulatory expertise is intense and the supply

requirements for these products across the

of available experts is an issue. Outsourcing

globe”, adds Katie Connelly, Vice President,

regulatory functions to a trusted partner with

Strategic Resourcing and Operations at PAREXEL.

a thriving global footprint can easily become a

“That is something that allows us to speak the

competitive advantage.

same language as our client counterparts. It allows us to quickly gain trust and establish a

“In some parts of the world,” adds Bergeron,

collaborative partnership.”

“PAREXEL knows not to simply put a dossier together and submit it based on rules and

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TECHNOLOGY TRUMPS TEDIUM As regulations change, so does technology, and technological advancements in regulatory compliance are crucial to gaining a competitive edge. Compliance agencies and health authorities now accept electronic submissions and tracking, which makes the entire process a bit easier. Companies outsource regulatory practices

PAREXEL’s Regulatory Information Management

because it keeps costs down and improves

(RIM) platform facilitates end-to-end submissions,

processes. These two areas benefit greatly from

centralizing the entire process. Launched in

technological expertise that an outsourcing

1994, our technology can be applied to individual

partner can provide by offering electronic

processes or to all of them. From defining

document submissions that capture the cultural

product authorization targets to creating

nuances and administrative procedures that

and gathering regulatory submission plans

change at every country’s border. It is a rare

to managing product registration and more,

biopharmaceutical company that would spend

the convenience, timeliness and benefit of a

potentially millions to build a program or acquire

technological edge should not be underestimated.

a pre-existing system and train its employees to

Outsourcing to a partner that can provide this leg-

use it.

up can be pivotal.

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EXPERTISE + EXPERIENCE = SUCCESS As of January 2013, 68% of biopharmaceutical companies were outsourcing regulatory affairs budgets,2 representing strong growth over the past decade as regulatory burdens increased. Regulatory outsourcing promotes efficiency, can leverage technology, and allows a company to focus on mission-critical needs. Each company ultimately determines what to outsource for a variety of reasons: It may have more launched products than teams can effectively handle in a timely fashion; it may need additional infrastructure support for drug development; it may want a partner to conduct clinical trials; and it may just want an expert to handle its international regulatory operations. All of these options, together or alone, are scalable and flexible. With an outsourcing partner, additional expertise can be brought in as needed. “Outsourcing costs are important but not

place to gauge the success of the partnership.

necessarily the driving factor in decision-making.

This also allows for benchmarking of best

Most of our clients are concerned with headcount

practices.

and the ability to manage and have flexible resources,” states Bergeron.

Timeliness and quality are fundamental in regulatory compliance and key to a solid

Shemanski agrees. “It’s the scalability and best

partnership in outsourcing. “At the end of the day,”

practices that make outsourcing a viable option to

stresses Connelly, “if we’re meeting timeliness

in-house staff.”

and quality metrics and the products are in a state of compliance, then we can confidently say we are

A regulatory outsourcing partner must have the

supporting the commercial success of our client.”

right metrics and key performance indicators in

Focusing on core competencies and outsourcing regulatory activities is a win-win for biopharmaceutical companies. Finding the partner with regulatory experience, international savvy and technological expertise may give a company a much-needed advantage in today’s demanding marketplace. 2 “Percentage of Pharmaceutical Companies Outsourcing Regulatory Affairs Budgets Increases to 68%”, BusinessWire [online], Jan 2013, http://www. businesswire.com/news/home/20130109005028/en/Percentage-PharmaceuticalCompanies-Outsourcing-Regulatory-Affairs-Budgets#.VIH8g3ZFDIV

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