This group specializes in aggregating information to meet requirements for global regulatory and standards bodies, including:

» Product Localizations
» ISO 9001 Compliance
» ISO 13485 Compliance
» ISO 14971 Compliance
» GAMP / ICH Compliance
» CE Mark Certification

Taika: Our name takes its inspiration from the Taika (大化) Reforms period in Japan. This was a unique period in Japanese history where brilliant/decisive leadership centralized and strengthened governance, enabling the country to escape the burden of feudal society stuck in a cycle of perpetual conflict and war.

Centralized control promotes communication, provides cost efficiencies and maintains higher quality standards. It keeps the focus on marketing and quality activities with the objectives of avoiding regulatory findings, while remediating possible process deficiences.