Regulatory & Strategic Development @ Clinipace | Page 2

We develop high-level regulatory strategies to expedite products through clinical
development and into the market. As a global digital contract research organization
(dCRO), we specialize in providing a full complement of strategic drug development
services for emerging to large multinational life science firms.
With extensive pharmaceutical, biotechnology and device knowledge, members
of our Regulatory & Strategic Development (RSD) team provide expert drug
development advice focusing on:

• Regulatory Strategy

• Product Development Strategy

Our extensive drug development expertise includes regulatory, medical, scientific
and technical writing. As a result, we can support you globally, from early, nonclinical
development, until late-stage life cycle management.
We offer services in the following practice areas:

• Strategic Development Consultancy

• Global Regulatory Affairs

• Clinical Trial Applications and Product Registrations

• Legal Representation (Europe Only)

• Regulatory Publishing

• GxP Auditing & Quality Assurance

• Chemistry, Manufacturing & Controls/Quality (CMC)

• Medical, Scientific and Technical Writing

• Due Diligence for Mergers, Acquisitions and Financing

With vast experience working with regulatory authorities around the world we
regularly represent our clients in meetings with these agencies, and can also act
as your legal agent. Frequent, direct interaction with regulatory authorities puts
us in a strong position when preparing and submitting regulatory dossiers for
pharmaceutical, biotechnology and device products.
Additionally, we provide post-marketing regulatory support, such as changes to
approved labeling, line extensions, manufacturing changes, label and promotional
materials review, license renewals, safety reporting and PSUR submission for Europe.

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