• Computer Systems Validation
  • Medical Device Data System Certification / Qualification
  • Change/Document Control Systems
  • Requirements Management Systems
  • SharePoint™ / .NET Customization
  • Content Management Systems
  • Product Localizations
  • ISO 9001 Compliance
  • ISO 13485 Compliance
  • ISO 14971 Compliance
  • GAMP / ICH Compliance
  • CE Mark Certification
  • 510(k) / PMA Submissions
  • FDA 21 CFR Parts 11/111/210/211/803/806/820
  • MDD 93/42/EEC Regulations
  • Japan MHLW (厚生労働省) Regulations
  • Canadian MDR Regulations
  • Design Controls/QSR Audits

Taika is the highest-quality, lowest-cost regulatory service provider for medical device, biotechnology and pharmaceutical organizations. Our co-operative/mutual aid style organization works collectively to expedite global regulatory approvals, and establish an ROI framework for regulatory compliance activities.

Our name takes its inspiration from the Taika (大化) Reforms 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, enables cost efficiencies and results in a higher quality standard. Our marketing-driven / unique approach is a proven, better way to maximize investments in regulatory and standards compliance. The objective is to bring patient care quality to the highest standards while doing our part to help keep costs down. We prioritize serving organizations which share our objective and which put patient care and safety first.