Pacific-Link Consulting Linking Global Strategic Development Experience, Excellence and Efficiency STRATEGIC DEVELOPMENT IN AN EFFICIENT MANNER How can you design the fastest pathway to enter human trial? PLC can evaluate the project objectives and design an optimal development strategy and facilitates clinical trials in any ICH region. What is the most efficient way to develop drug? PLC can support your efforts to design the most efficient development program in consultation with Regulatory Agencies. How do we resolve difficult situations with Regulatory Agencies? PLC has expertise to manage interactions and negotiations with Regulatory Agencies in the US (FDA), EU (EMA and National) and Japan (PMDA). PLC has extensive experience managing negotiations to remove clinical holds and build positive relationships. We are considering investment in a venture, does the product strategy sound right? PLC can support your due diligence needs to assess potential for success of venture companies with novel ideas. www.pacificlinkconsulting.com US Office 8195 Run of the Knolls CT San Diego, CA 92127 Phone: +1-858-335-1300 Fax: +1-858-769-0288 Contact: richard@pacificlinkconsulting.com Tokyo Office 8-903 Fukuromachi, Shinjuku-ku Tokyo 162-0828 Japan Contact: sarina@pacificlinkconsulting.com Richard Lowenthal, MS, MSEL Sarina Tanimoto, MD, PhD We are committed to supporting our clients to meet their business objectives, project milestones and customizes our approach to the situation and needs of the client company.