At-A-Glance: RSD Global Consulting CW_RSDGlobal_Consulting_FINAL_July27_2017 | Page 2

Operations Support: Executing your Plans
Competent execution of a plan is as essential to success as the plan itself. Our global team
of operations professionals serve as the stewards of your program—managing timelines,
costs, and quality at every step of the way. The RSD Global Consulting team provides the
following services:
Regulatory Affairs
Medical and Regulatory Writing
• INDs, Clinical trial applications, and
IMPDs • Study protocols and amendments,
investigator brochures, and CSRs
• NDA, BLA, ANDA, 505b(2), MAA, DMF
writing, and project management • Clinical evaluation reports (CERs) for
medical devices
• Special regulatory designations (break
through, fast track, advanced therapy
medicinal product (ATMP) • Clinical summaries and overviews,
ISS/ISEs (modules 2.5, 2.7, 5.3.5.3)
• Risk management plans (RMP), Risk
evaluation and mitigation strategies
(REMS)
• Orphan drug designation
• Pediatric investigation plans (PIP)
and Pediatric study plans (PSP)
• Consulting on EU confidentiality and
clinical data publication policy 0070 and
US clinical trials registration and results
information submission rule FDAAA801
• Lifecycle and dossier maintenance,
Post-marketing changes
• Study Reports, Journals, and
Manuscript Preparation
• Package insert (PI), summary of product
characteristics (SmPC), and Patient
information leaflets (PIL)
• Biosimilars
Manufacturing and Quality Support
• Quality System/SOP development,
training, and implementation
• GMP, GLP auditing and remediation
• CMO and Supply chain management
• Vendor section and qualification
• Writers fluent in English and
regional languages
Regulatory Publishing/Submission
• eCTD publishing and submissions
• SPL
• CSR regulatory compliance advisement
Consulting Services and Expertise - Tailored to Your Specific Development Needs
Clinipace’s RSD Global Consulting team is ready to help whether you need a single submission to
a regulatory authority, or full strategic and operations support to assist you in the development of
your program. Either way, we are committed to your success!
Learn more, contact us at +1 919.224.8800 or visit clinipace.com.