We serve life sciences manufacturers where validated production systems, GxP compliance, and patient safety are not compliance checkboxes. They are operational requirements that directly affect product quality, regulatory standing, and the people who depend on the medicines and devices you manufacture.
Drug manufacturers operating under 21 CFR Parts 210/211 and cGMP requirements. ERP validation in pharmaceutical manufacturing demands rigorous IQ/OQ/PQ documentation, audit trail integrity, and change-controlled operations at every production system layer. All are subject to FDA inspection at any time.
Biologics and biosimilar manufacturers where validated production systems underpin batch record integrity, manufacturing execution, and quality event management. Biotech manufacturers scaling from clinical to commercial production face particularly complex ERP validation requirements as manufacturing processes and regulatory oversight intensify.
Advanced therapy developers transitioning to commercial biologics manufacturing, including cell and gene therapy manufacturers, operating at the frontier of regulated production. These programs require ERP validation expertise calibrated to complex, patient-specific manufacturing processes, evolving FDA guidance on ATMPs, and quality systems supporting the traceability demands of autologous and allogeneic therapies.
Class II and Class III device manufacturers operating under 21 CFR Part 820 (QSR) and ISO 13485. ERP and quality system validation in medical device manufacturing spans design controls, complaint handling, CAPA, and production process validation. All require validated system support under FDA and EU MDR/IVDR requirements.
Contract development and manufacturing organizations face compounded complexity: maintaining multiple client quality systems within a single validated ERP infrastructure. CDMO and CMO manufacturing environments require professionals who understand multi-client GMP production operations, quality agreement compliance, and the validation implications of shared systems serving diverse pharmaceutical and biotech manufacturing customers.
Life sciences manufacturers operating across the GxP spectrum, with particular focus on Good Manufacturing Practice environments, where validated production systems must support compliant data integrity, manufacturing operations, and supply chain quality. These environments require professionals who understand GxP manufacturing obligations and their validated system dependencies.
Large molecule biologics and vaccine manufacturers where validated ERP and production systems are integral to lot release, batch record management, and regulatory submission integrity. These manufacturing environments require professionals who understand the process analytical technology, cold chain traceability, and sterility assurance demands unique to biologics GMP manufacturing.
Specialty pharmaceutical manufacturers, including sterile injectables, oncology products, and OTC manufacturers, where product complexity and risk profile drive stringent manufacturing validation requirements. Sterile manufacturing environments require validated ERP systems that support environmental monitoring, cleanroom controls, and aseptic production process documentation.
Pharmaceutical and biotech quality control and analytical laboratories that directly support manufacturing operations, where LIMS, chromatography data systems, and enterprise quality platforms must be validated under GLP and GMP requirements. These environments demand professionals who understand data integrity, instrument qualification, and the integration of laboratory systems with broader manufacturing ERP quality infrastructure.
Every search, every candidate evaluation, and every client engagement operates within the context of FDA-regulated, GxP life sciences manufacturing. We do not split this practice across industries. That concentration is what makes it possible to screen with the specificity that pharmaceutical, biotech, medical device, and CDMO manufacturing organizations actually need.
Tell us about your manufacturing organization, validated production environment, and talent need. We'll scope the search against your specific GxP manufacturing context.