Pharmaceutical and Life Sciences Industry Support

Pharmaceutical & Life Sciences Industry

FDA-regulated environments demand more than compliance awareness. They demand assessors who understand what the regulations actually require.

Pharmaceutical developers, manufacturers, medical device companies, and biotech firms operate under some of the most demanding regulatory environments in any industry. DEA electronic prescribing requirements govern how controlled substances are prescribed and dispensed electronically

FDA CFR 21 Part 11 extends into electronic records and signatures across quality management, clinical trial data, and manufacturing controls. Alongside these obligations, organizations in this industry typically carry HIPAA exposure through clinical and research data handling, and supply chain credentialing requirements through pharmaceutical distribution networks.

These requirements do not exist in separate compliance lanes, and an assessor who understands only one of them will miss the exposure that lives at the intersections.

Services

Testing & Certification

Compliance Audits & Support

HIPAA

FDA CFR 21 Part 11

Risk & Security Assessments

Compliance Expertise Across DEA, FDA, HIPAA, and Supply Chain

Drummond is a DEA-approved third-party auditor for electronic prescribing of controlled substances—one of the most operationally specific compliance requirements in the pharmaceutical industry. That authorization was not acquired recently. Drummond built one of the first DEA-approved EPCS audit programs and has operated it continuously since.

Combined with cross-framework experience across FDA CFR 21 Part 11, HIPAA, supply chain credentialing, and security assessments, Drummond brings a depth of pharmaceutical compliance knowledge that comes from decades of work inside this industry, not adjacent to it.