Regulatory and Analytical Support Services

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 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.

Analytical Support

SPL’s quality control and microbiology laboratories are fully validated. We utilize numerous standards and compendial methods for in-process and release testing of drug products.

We also have the capability to develop, qualify and validate a wide range of non-compendial analytical test methods.