Pacific-Link Consulting


Biotechnology Project Management


Pacific-Link Consulting offers comprehensive development support and consultation for medicinal product development in the United States, and Japan, as well as Europe through our partnership with Sirius Ltd. Our services include strategic development for biologics and drugs with expertise in regulatory strategy, regulatory operations (submissions), clinical development, clinical operations, pharmaceutical development, business development, auditing, and quality management, and medical writing. Our consultants have particular expertise with obtaining Orphan Drug Designations in Japan and the United States for novel biologics and drugs with a successful track record of approves through the PMDA and FDA. We also specialize in Japanese Bridging Strategies and clinical trial applications in Japan for Orphan Drug products. Pacific-Link is committed to support clients to meet their business objectives, project milestones and customizes our approach to the needs of the client company.