Spectral Data Services, Inc. is in full compliance with the GLP (Good Laboratory Practice) regulations mandated by the EPA (Federal Register 40 CFR part 160) and the FDA ( Federal Register 21 CFR part 58), and the GMP (Good Manufacturing Practice) regulations mandated by the FDA (Federal Register 21 CFR Part 211), and is registered with the FDA. We have a full-time, dedicated quality assurance specialist in-house to insure compliance and validation. Of course, our clients are welcome to perform their own audits of our facility.

In addition to providing NMR results with GLP/GMP compliance, we also can prepare protocols and study reports, provide method validations, and conduct audits and inspections.

We are also licensed with the Drug Enforcement Administration (DEA) as an analytical laboratory performing NMR analyses of controlled substances. The required security, personnel, and record keeping measures have been implemented, and the analytical staff has been trained in appropriate written procedures. With this registration, we are allowed to handle controlled substances under DEA Schedules II through V.

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