cGMP Compliance
SPL’s facilities are operated strictly in accordance with FDA’s cGMP requirements. Experienced and dedicated quality assurance and regulatory staff are committed to providing complete regulatory support for our customers.

Excellent Inspection History
SPL is regularly inspected by multiple regulatory agencies such as the FDA and USDA and participates in many annual customer audits. We maintain a stellar regulatory inspection record by doing things right the first time and maintain that commitment to excellence every day of the year. Ask us about our inspection history and results…or check us out yourself! www.fda.gov/cder/dmf, www.usda.gov

Support for Development Projects
In the area of Custom Biopharmaceutical Development and Manufacture, we are able to support our clients in every aspect of Regulatory Compliance, including providing CMC sections of IND, NDA, aNDA and by developing and maintaining in good standing numerous Drug Master Files. We also provide complete process validation and equipment qualification in support of our customers' regulatory filings.

Global Consistency
Importantly, SPL has gone to great lengths to ensure that consistency in compliance is maintained at both of our global manufacturing sites in Waunakee, WI and Changzhou, China. We rigorously apply the same work processes, documentation requirements and QA/QC regimen at both facilities to provide our customers with the reliability and peace of mind they value no matter where SPL products are sourced around the world. FDA-approved APIs from both sites are supported by an ever-expanding list of Drug Master Files, Import Certificates, EU Certificates of Compliance and other documentation that makes sourcing APIs through SPL simple and worry-free.

We invite you to speak to our Regulatory Compliance experts to learn more about how SPL is able to deliver this seamless performance on both sides of the Pacific Ocean!

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