One vendor for the regulated work that keeps a 503A or 503B running

What we deliver across all three audiences

• USP <797> / <800> / <825> compliance — viable air, surface, and gloved fingertip sampling; media fill testing; primary engineering control certification (BSCs, LAFWs, CAIs, CACIs); cleanroom recertification; dynamic smoke studies; HEPA integrity; personnel competency assessment.
• FDA cGMP equipment qualification — calibration under A2LA Cert 2039.01 directly satisfies 21 CFR 211.68. Equipment qualification, calibration scheduling, NIST-traceable certification, audit-ready documentation across balances, pipettes, thermometers, pressure gauges, refrigerators, freezers, autoclaves, incubators, environmental sensors.
• Cleanroom certification — annual and semi-annual recertification of ISO Class 5/7/8 cleanrooms. CETA RCCP and NSF Accredited Technicians.
• Biosafety cabinet certification — NSF/ANSI 49 Class I, II (A1/A2/B1/B2/C1), Class III. NSF/ANSI 49 Field Certifier credentialed technicians.
• LAFW certification + CAI certification + CACI certification — primary engineering controls under USP <800>.
• Cleanroom commissioning for new and renovated facilities — Precision Biotech Solutions delivers IQ/OQ/PQ documentation, ISO 14644 classification, HEPA integrity, pressure cascade mapping, NEBB TAB.
• Accredited environmental monitoring — viable air, surface, and fingertip sampling collection by Allometrics. Incubation, microbial enumeration, and identification by Taylor Lake Laboratories under A2LA Cert 7533.01 — one of the few labs in the nation with A2LA accreditation specifically for environmental monitoring.
• Air balancing and HVAC TAB — NEBB-credentialed TAB by Precision Biotech Solutions for facilities maintaining cleanroom HVAC balance, pressure cascades, and ventilation per USP and (where applicable) ASHRAE Standard 170.
• Temperature & humidity mapping — pharmacy storage rooms, controlled-temperature warehouses, ULT freezers, refrigerators. IQ/OQ/PQ qualification reports.

Why pharmacies and manufacturers consolidate with Allometrics

Regulatory continuity across the chain. Whether your facility operates under USP only, FDA cGMP only, or both simultaneously, Allometrics' A2LA Cert 2039.01 calibration documentation and A2LA Cert 7533.01 biological testing satisfy the regulator your buyer is being held to. State board inspectors, Joint Commission surveyors, and FDA investigators all recognize the same accreditation chain.

Single accountable organization for the cleanroom lifecycle. Cleanroom commissioning by Precision Biotech Solutions → ongoing recertification by Allometrics → environmental monitoring by Allometrics + Taylor Lake Laboratories → equipment calibration by Allometrics — all on one continuous data record under shared accreditation. Most pharmacies coordinate this across three or four vendors. Allometrics keeps it inside one Group.

Operational fit for multi-facility 503B and pharmaceutical operators. Centralized scheduling, consistent reporting formats, alignment with the operator's centralized procurement structure, single escalation path. For 503B operators with multiple compounding sites and pharmaceutical manufacturers with distributed production, this consolidation reduces compliance overhead.

Audit-time guarantee. If a calibration, certification, or qualification report we delivered is challenged in an FDA, USP, state board, Joint Commission, or customer audit, we will address it. Records on IndySoft — 21 CFR Part 11–compliant electronic records and signatures.

50 years of pharmacy and manufacturing experience. Founded 1976. 1,800+ customer accounts. Continuous through every USP revision, every FDA cGMP guidance update, every state board reform.