Regulatory & Strategic Development @ Clinipace | Page 4

Medical, Scientific & Technical Writing
Our writers prepare all relevant documents, e.g. expert reports, summaries,
investigator brochures, protocols, response documents, orphan drug applications,
fast track applications and clinical study reports to meet regulatory authority
requirements. Our team of experienced regulatory scientists can write the
nonclinical, clinical and CMC sections in CTD and traditional format for your new
drug and biologic applications. We have extensive experience writing Drug Master
Files for international product registrations.

Legal Representation
Clinipace Worldwide regulatory consultants provide legal representation for
clients in their interactions with regulatory authorities, and our consultants have
represented clients and are authorized to act as their legal entity with authorities
across the globe.

Standard Operating Procedures (SOPs)
We can write SOPs for your specific compliance needs, whether they are GLP, GMP,
QSR or GCP. We will work with you to implement the SOPs and provide training in
their use. Clinipace can also provide quality manuals for your organization.

International Registration
Our team has successfully registered new chemical entities, biologicals, generic
medicinal products, biosimilars and devices for the US and European markets. In
addition, our expert regulatory professionals prepare variations and amendments
to existing licenses, and can assist you with environmental assessments, REMS/RMP,
PSUR, license renewals and annual reports. We prepare our a pplications using the
internationally recognized electronic Common Technical Document format. We file
all clinical trial and market approval applications with the Regulatory Authorities,
including SPL labeling, drug registration, establishment license renewals, variations
or any necessary submission.

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