2. Solutions designed to streamline approval
Every day your therapy sits in the development pipeline costs
you money and costs patients the opportunity for treatment.
At Cardinal Health Regulatory Sciences, we know how critical it
is to get it right the first time at every step of the development
process. We’ll partner with you to devise the best pathway
for your therapy from inspiration to marketing approval and
beyond.
Our scientists have decades of experience with biotechnology
and pharmaceutical products and medical devices. Whether
it’s assisting you with your regulatory strategy or serving as
a trusted partner to augment your internal resources, we’ll
integrate seamlessly with your organization and your processes
to deliver reliable results.
The Cardinal Health Regulatory Sciences team has insight and
a deep understanding of the regulatory process, both as it
stands and how it will evolve. With strong ties to the regulatory
agencies and vast knowledge from past engagements with
clients large and small, we know how to artfully navigate even
the most complex approval processes.
Our approach to ensure your therapy’s approval is to apply our
proven understanding of the science behind the therapy and
the science required to support approval. Our experience allows
us to work efficiently through all aspects of the development
program. In addition, we focus on accuracy and attention to
detail. We know speed is only efficient when combined with
quality, so we do our utmost to deliver both.
From development to
launch without delay
Worldwide
Regulatory
Development
Strategies
Chemistry,
Manufacturing,
and Controls
Nonclinical
Development
Clinical
Development
Medical
Writing
3. As your trusted partner on this journey, we look beyond the
technical aspect of our work. We consult closely with you to
ensure that, together, we take the right steps at the right time.
There’s risk in any development process, and together we can
identify, evaluate, and reduce the risk.
It can be a long journey from identifying a product candidate
to delivering treatment to patients. Cardinal Health Regulatory
Sciences is committed to being a great partner along the way,
keeping our eyes focused on the same horizon as you: securing
approval and bringing your therapy to market and to the
patients who need it most.
Regulatory
Publishing
Services
Compliance
Services
Launch and
Postapproval
Services
Training
Services
Develop scientific and
regulatory strategies
designed to meet global
requirements
Prepare regulatory
documentation for
investigational and
marketing applications
Compile electronic regulatory
submissions according to the
eCTD guidelines
Prepare postapproval
submissions and required
state licenses
