Regulatory & Strategic Development @ Clinipace | Page 5

Chemistry, Manufacturing & Control (CMC) Dossiers for
Drug Registration
Clinipace’s CMC team offers both expert strategic advice and high-quality regulatory
submissions, giving you access to the widest possible market for your product in
the shortest possible time. We have developed strong relationships with authorities
around the globe, and regularly represent our customers at critical agency meetings.
Our experience encompasses international registrations of new chemical and
biological entities, preparation of Module 3 documentation for drug registration,
and pharmaceutical products containing established active ingredients.

GxP Auditing, Quality Assurance & Training
Clinipace provides expert quality assurance consulting services to pharmaceutical,
biotechnology, medical device and dietary supplement companies to help ensure that
they are in compliance with current business practices and regulations. Our team
of auditors can perform a detailed assessment of your existing quality systems and
processes to highlight problem areas and recommend improvements. We can assist you
with all aspects of compliance, as they impact your product, including GLP, GMP, QSR and
GCP. We can also conduct similar activities on your behalf for third-party contractors.
Additionally, we assist clients in:
• Completing post-audit follow-up actions
• SOP writing and system implementation services
• Managing CMC projects with third-party vendors and contract facilities
• Preparing and reviewing third-party quality agreements for contract manufacturers
• Training and Regulatory Authority Inspection preparation
The audits will be tailored to your particular compliance needs and relevant for the
stage of product development. Our QA team has performed audits in the US, Canada,
Europe, Asia and Pacific Rim.

GxP Compliance Training
It is important to make sure that everyone in your team understands the relevance of
quality systems and knows how to apply them to your programs. With our extensive
experience and well-qualified personnel, we can provide training in all aspects
of GLP, GMP, QSR,and GCP, providing insight into European, US FDA, WHO or ICH
guidance and regulations to meet the needs of your specific project.

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