At-A-Glance: RSD Global Consulting CW_RSDGlobal_Consulting_FINAL_July27_2017

AT-A-GLANCE Regulatory and Strategic Development Global Consulting Helping you accelerate approval times - Ensuring sound decisions are made at every stage of the product lifecycle Your Global Drug Development Partner Moving drugs and biologics from the bench into the clinic and on to market approval requires significant breadth and depth of expertise across technical, regulatory, and quality disciplines. Our experienced scientists and regulatory professionals work closely with our clients to ensure a sound development strategy is defined and executed. With offices and expertise in the US, Europe, and Asia Pacific, the Regulatory and Strategic Development (RSD) Global Consulting team has the experience needed to create drug development strategies to meet your specific needs. From traditional small molecules to advanced biologics, across the complete array of dosage forms and a wide range of therapeutic areas, we will help you plan and advance your program into the clinic, Strategic Consulting: Creating the Roadmap Integrated strategic solutions are essential to the successful development of today’s therapeutics. Our offerings include: Product Development Biotstats Services • Registration and overall regulatory strategy • Protocol development – Power analysis, randomization plans • Statistical analysis of data – Creation of SAP and TLF’s • CMC development strategy • Needs/gap assessments • Agency interactions and scientific advice • Product lifecycle support • Scientific and medical writing Portfolio Management • Due diligence – In-depth quality, regulatory, and management assessments • Portfolio development and evaluation • Product and regulatory intelligence • Clinical events committee – Establishment and management • Summary Reports – Contribute to CSR, ISS/ISE, DSUR, MAA, and others • Statistics consulting and agency interactions • CDISC – SDTM deliverables, ADaM deliverables