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Quality Certificates

WuXi AppTec’s corporate commitment to quality is reflected in the quality programs/systems at its U.S. sites located in St. Paul, Minnesota; Atlanta, Georgia; and Philadelphia, Pennsylvania.

For the convenience of our clients, we are also pleased to make available the following PDFs of accreditation/registration certificates for viewing or downloading.

Accreditation & Registrations

St. Paul, Minnesota

[Contract Manufacturing] American Association of Tissue Banks (AATB) Accreditation

[Contract Manufacturing] BSI Certificate of Registration: Quality Management System – ISO 13485:2016

[Contract Manufacturing] State of California Tissue Bank License

[Contract Manufacturing] State of Maryland Tissue Bank Permit

[Contract Manufacturing] State of New York Provisional License for Tissue Banks

[Contract Manufacturing] State of Florida Tissue Bank Certificate

[Biocompatibility] A2LA ISO/IEC 17025:2017 Accreditation

[Chemistry] A2LA ISO/IEC 17025:2017 Accreditation

[Biocompatibility] EMA Certificate of GMP Compliance

[Biocompatibility/Contract Manufacturing] Food and Drug Administration (FDA) Drug Establishments Registration
[Chemistry] Food and Drug Administration (FDA) Drug Establishments Registration
[Biocompatibility] Therapeutic Good Administration (TGA) of Australia GMP Certification

Atlanta, Georgia

American Association for Laboratory Accreditation: Certificate of Accreditation – ISO/LEC 17025:2017

Food and Drug Administration (FDA) Drug Establishments Registration

International Safe Transit Association (ISTA) Certificate of Membership as Certified Testing Laboratory

EMA Certificate of GMP Compliance

Food and Drug Administration (FDA) Establishment Registration and Listing for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/PS)

download pdf

Note: The U.S. Food and Drug Administration (FDA) does not issue hardcopy certificates for Drug Establishments Registration. The link above is to a PDF (screen capture) of the FDA website page that verifies the Drug Establishments Current Registration for WuXi AppTec U.S. facilities.​

Philadelphia, Pennsylvania

American Association for Laboratory Accreditation: Certificate of Accreditation – ISO/LEC 17025:2005

Food and Drug Administration (FDA) Drug Establishments Registration

State of Maryland Tissue Bank Permit

EMA Certificate of GMP Compliance

American Association of Tissue Banks (AATB)

Food and Drug Administration (FDA) Establishment Registration and Listing for Human Cells, Tissues and Cellular - and Tissue-Based Products (HCT/PS)

download pdf

Note: The U.S. Food and Drug Administration (FDA) does not issue hardcopy certificates for Drug Establishments Registration. The link above is to a PDF (screen capture) of the FDA website page that verifies the Drug Establishments Current Registration for WuXi AppTec U.S. facilities.​

Unmatched expertise for biologics, medical devices and combination products

Our team has a proven track record developing customized programs that leverage our many years of industry-leading experience. We provide the wide range of services and guidances required to launch and maintain successful products in today’s complex regulatory environment.