Pharmaceuticals & Healthcare
Regulatory, Quality & Audit Support
A dedicated regulatory team spanning India, Japan, and Korea, supporting manufacturers through audits, filings, and regulatory submissions.
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Markets covered: India, Japan, Korea, China
DMF & AFM
Filing and lifecycle maintenance
End-to-end
Guidance through to final submission
Overview
A dedicated regulatory team across India, Japan and Korea, forming the link between manufacturers and the regulatory authorities that govern them.
Regulatory compliance and quality are the backbone of any healthcare business, with external, long-term implications that make them just as significant as pricing. This is where a partnership with Kyodo becomes genuinely valuable.
We maintain a dedicated, experienced regulatory team across India, Japan, and Korea, forming the link between manufacturers and regulatory authorities in all three markets, plus China. We support our manufacturing partners with guidance, audits, compliance, recommendations, and final submissions, including technology transfer documentation for innovator APIs and intermediates, mock audits, joint customer audits, assistance during regulatory inspections, and DMF filing and AFM maintenance.
Regulatory compliance and quality carry external, long-term implications, which makes them every bit as significant as price.
What we have delivered
Technology transfer documentation
Technical transfer files for innovator APIs and intermediates.
Mock audits
Pre-inspection mock audits to surface gaps before regulators do.
Co-customer audits
Joint customer audits conducted alongside partners.
Inspection support
Assistance during regulatory-body inspection of manufacturing sites.
DMF filing
Drug Master File preparation and submission.
AFM maintenance
Ongoing Accreditation of Foreign Manufacturer lifecycle upkeep.