YS Pharma Consulting provides end-to-end regulatory solutions for companies entering the U.S., Canadian, and Chinese markets. We specialize in licensing, FDA and Health Canada registrations, NDC and NHP submissions, GMP compliance, and cross-border consulting.
What sets us apart is hands-on execution experience combined with deep regulatory knowledge. We guide clients through real applications and approvals, helping them avoid delays, reduce risks, and succeed in new markets.
Our mission is to make regulatory compliance clear, efficient, and reliable, empowering international manufacturers and healthcare companies to confidently expand into North America and China.
US GMP Warehouse Consulting
Ensure your U.S. pharmaceutical warehouse meets GMP standards with expert guidance on licensing, SOPs, and compliance for smooth, audit-ready operations.
US Regulatory Consulting
Full support for FDA registration, NDC registration, U.S. 50-state licensing (wholesale, 3PL & manufacturing), and API /FP importing.simplifying complex regulations for efficient market entry.
Drug Product Submissions
Expert support for NDS, ANDS, and post-market submissions for fast, accurate approvals and smooth regulatory compliance.
Canada Facility Licensing
Expert guidance for DEL, NHP Site License, and MDEL applications, amendments, renewals, and ongoing compliance, keeping your facilities fully licensed and audit-ready.
Drug/Natural Health Product Submissions
Support for NDS, ANDS, DIN, and NPN applications, ensuring accurate submissions, timely approvals, and regulatory compliance.
Regulatory Strategy & Compliance
GMP consulting and API/FP import auditing to ensure full compliance with Health Canada regulations and a smooth market entry process.
Facilitating partnerships between international companies and Chinese pharmaceutical manufacturers.
We provide end-to-end support including regulatory guidance, sourcing, compliance auditing, facility verification, and quality management. Our services help clients navigate Chinese regulations, streamline supplier selection, ensure product quality, and maintain smooth, risk-free cross-border operations.
Opening hours
Mon - Fri: 9am - 5pm
Saturday: By appointment
Sunday: Closed
Phone: 1-437-888-4484
Email: yspharmaconsulting@gmail.com
© 2019 YS Pharma Consulting