85WHERECOMPANIES DO

BUSINESS %

33%

48%

22%31%

Primary rationale for outsourcingREGULATORY AFFAIRS WORK

33%To temporarily

manage overflow

26%To increase

capacity

19%Other

responses

17%To enable in-house staff

to focus on strategic work

5%To save cost

outsource less than10% of their budget50%

outsource more than25% of their budget32%

Estimated percentageof totalREGULATORY AFFAIRS BUDGETthat is outsourced:

MOST IMPORTANT FACTORS WHEN SELECT ING AN

OUTSOURCING PROVIDEREXPERIENCE

COSTTHERAPEUTIC KNOWLEDGE

FIT

Internet search

8%

Leveraging our in-house procurement team

10%

Working with a large CRO

13%

Using referrals from trusted sources

69%

FUNCTIONS HANDLED BY THEREGUL ATORY DEPARTMENT AT YOUR COMPANY?

Label review of regulatory signoff

Advertising regulatory signoff

Regulatory CMC

Pharmacovigilance

Quality assurance

Study startup

Environmental considerations

Market access or reimbursement

FOR OUTSOURCING OVER THE NEXT 12 MONTHSTOP AREAS

Regulatory strategy

Pharmacovigilance

Regulatory operations(publishing)

Overflow submissions

Regulatory writing

Mature marketedproducts support

Regulatory CMC

Quality assurance

Labeling

In the first quarter of 2013, Optum Life Sciences surveyed 46 small, mid-size and large life science companies to gauge their regulatory outsourcing practices and plans. Companies represented a range of therapeutic areas — predominantly oncology, CNS, GI, CV and respiratory. Below is a closer look at their regulatory outsourcing activities.

O U T S O U RCI N GP R OV I D ER SARE FOUND

What regulatoryexecutives thinkabout outsourcing

HO

W

outsource 11-25% of their budget

18%

Optum Life Sciences