Pharmaceutical Technical Services

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The Principal of PTS, Joseph T. Busfield, has worked with many companies, in the U.S., Europe, and other parts of the world to perform compliance audits and/or develop sustainable production and facility compliance programs. PTS develops programs that can sustain regulatory scrutiny and, more importantly, produce products compliantly and engineer, maintain, and calibrate systems and equipment correctly. Performing these production and operations-based engineering functions correctly is good business, good economics and compliant. The regulatory requirements should not be perceived as a burden, rather a guide to help an organization establish robust systems to ensure product is made consistently, meeting pre-determined quality requirements.

The Principal of PTS has been helping start-up and established companies as well as those under "regulatory distress" for years, working with corporate and site personnel to develop standards and administrative procedures for calibration activities. Some clients were proactive in setting up the programs before problems arose or as preparation for regulatory review of new facilities. Many other sites have implemented our calibration and/or maintenance programs, after receiving a Warning Letter or entering into a Consent Decree with the FDA.

The Principal of PTS has been helping start-up and established companies as well as those under "regulatory distress" for years, working with corporate and site personnel to develop standards and administrative procedures for maintenance, calibration, and internal engineering activities. Numerous sites have implemented our calibration and/or maintenance and engineering programs, some working under a Consent Decree or having received a Warning Letter. Some clients have been proactive in setting up the programs as preparation for regulatory review of new facilities or just out of a desire to establish compliant programs.

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