Regulatory & Strategic Development @ Clinipace | Page 3

Global Regulatory Expertise
Clinipace Worldwide offers you a team of regulatory affairs professionals who provide
extensive experience working with regulatory authorities around the world. Our
expertise ensures strategies and alternatives are considered at every step to help you
gain product registration.
Our team will work with you in both pre- and post-marketing drug safety regulations,
document management, regulatory filings, global marketing authorization applications,
variations and renewals and carefully developed due diligence strategies.
Our Regulatory Affairs services include:
•  rite and review technical dossiers and
W
developmental plans
•  esearch and interpretation of
R
applicable local regulations
•  etermination of product registration
D
strategy
•  eview and support of manufacturing/
R
GMP issues

• Post-marketing support (labels,

variations and reports)
• Regulatory authority liaison
•  ll services related to regulatory
A
applications and filings
• Orphan drug designations
• REMS and risk management services

Regulatory Publishing
Clinipace Regulatory Operations supports the production of submissions in both
paper (CFR and CTD) and electronic formats. Whether you are submitting an original
application for a clinical trial; a variation to an existing application; or a conversion
of an existing application to eCTD format; we can publish and deliver an FDA/ICHcompliant submission to meet your needs.
We work with industry leaders to stay at the forefront of eCTD requirements. By
using our own highly qualified and experienced in-house staff to perform most of
the e-publishing, and limiting the use of third party e-submission vendors to highly
specialized activities, we can offer affordable e-submissions to our clients.

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