PA V
R i
2 2 TN si u
-2
Boo 4 • OERSs at
t # RL ANHIP
D S
AP
RI
L
53
3
O
WHEN YOU NEED
STRATEGIC
REGULATORY
AFFAIRS,
THEOREM.
The right set of experts can help maximize the value
of your development program.
Brian Bollwage, JD
Vice President,
Global Regulator y Afairs
STRATEGIC APPLICATION OF REGULATORY EXPERTISE REDUCES COSTS
AND IMPROVES PROFITS.
Starting well before clinical trials are initiated, Theorem's Strategic Regulatory Afairs (SRA) specialists do the work necessary
to understand both the regulatory landscape and relevant precedents for your drug or medical device. Early regulatory
guidance in these areas can help reduce development costs, smooth the development path and improve post-approval marketing
potential. When you need regulatory afairs to go beyond mere compliance, don't give it a second thought. THINK THEOREM.
Regulatory consulting
Drug development strategy
Authorized regulatory liaison
Guidelines and precedents analysis
Product label claim optimization
Simplifying t mot comple
CLINICAL TRIALS.
Biopharmaceuticals \\ Medical Device \\ Diagnostics
Submission design and execution in all formats
Global submission strategy
Regulatory risk analysis
Reimbursement strategy
W
www.TheoremClinical.com
,F
L