Regulatory – Japan
Pacific Link Consulting can provide extensive services throughout Japan with an office located in Tokyo. Our team has cultivated a deep understanding of local regulations and has established relationships with health professionals and business partners across the country. With this direct access, our team is able to handle all your regulatory needs throughout Japan, including:
• Cost-effective regulatory strategy development and consultation
• Medical and technical writing for regulatory submissions
• Development of Asian bridging studies
• PMDA and MHLW interactions and meeting packages – preparation and conduct
• Support CRO activities throughout Japan
• KOL liaison work
• Translation work
The above list of services is not comprehensive. Please contact us with your individual project needs so we may provide you with more information tailored to your requirements. We look forward to developing a successful regulatory plan that will meet your needs, timelines, and budget.
Other markets of expertise we serve include the United States, Canada and Europe. Pacific-Link Consulting offers comprehensive assistance to all of these key markets, from navigating unique regulatory environments to managing clinical trials (including developing clinical protocols, trial monitoring and data management) backed by over 25 years of experience.
Please contact us to learn more about what Pacific-Link Consulting can do for your project.