We provide technical and regulatory consulting services to pharmaceutical companies and their suppliers of excipients and packaging materials. We are based in Japan but work globally with clients and regulatory authorities in Japan, US, EU, Canada, and China. Our expertise covers all aspects of manufacturing and quality control (CMC) for drug products, APIs, excipients, packaging materials, and drug delivery systems.
We design practical CMC strategies and work with clients to ensure high-quality GMP-compliant operations that meet international safety, quality, and regulatory requirements. With over 25 years’ CMC and regulatory affairs experience, we are well positioned to handle:

• CMC issues
• GMP & IPEC GMP Gap-analysis Audits
• CTD Documentation
• Regulatory Deficiencies
• Master File (MF) registration and lifecycle management (Japan, US, Canada, China)