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MORRISVILLE, NC, Aug. 03, 2017 (GLOBE NEWSWIRE) - Clinipace Worldwide, a global full-service clinical research organization (CRO), has launched a new regulatory and strategic development consultancy called RSD Global Consulting (RSDGC).
With more than 50 specialists, Clinipace RSD Global Consulting provides strategic consulting and regulatory support in the U.S., Europe, and Asia Pacific. RSDGC offers stage-specific solutions for all phases of development, from non-clinical and clinical, through to marketing applications and post-marketing support. The group also provides all aspects of pharmaceutical development support, including chemistry, manufacturing, and controls (CMC) strategy; dossier preparation; pre-approval inspection (PAI) preparation; GxP auditing for compliance in pre-clinical (GLP), clinical (GCP), manufacturing (GMP), medical/regulatory writing, strategic biostatistics and a quality assurance (QA) consultancy.
“Whatever the scale or complexity, RSD Global Consulting has the breadth and depth of technical, regulatory and quality expertise to take promising therapies from bench to bedside,” said Nikolas Burlew, who was recently appointed as Executive Vice President of RSD Global Consulting. “Our RSD Global Consulting team applies pragmatic approaches to the complex challenges of drug development, managing costs, quality, and deliverables to ensure that our clients’ goals are met.”
“We are delighted to launch this new consultancy in response to customer demand, especially amongst the early state biotech and pharma companies that we serve” said Clinipace President and CEO Jeff Williams. “We can work with companies of all sizes, from early-stage biotech firms, through to clinical stage and multinational. From traditional small molecules to advanced biologics, across the complete array of dosage forms and a wide range of therapeutic areas, we can help customers plan and advance their programs into the clinic, to regulatory approval and beyond.”
Sandra Parrish Woodlief