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.

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.