Core Services
Eight specialized practice areas covering quality systems, qualification, validation, training, project management, and implementation support — for FDA, EMA, and EU GMP-regulated industries.
Each Core Service is led by senior practitioners with decades of regulated-industry experience. Click into a service to see the full capability set, deliverables, and applicable industries.
Quality Systems & Regulatory Compliance
CAPA, change control, GxP audits, document management, and business continuity for FDA, EMA, and EU GMP-regulated operations.
Learn moreFacilities & Utilities Qualification
IQ/OQ/PQ planning, protocols, and reports for HVAC, water systems, clean utilities, and classified manufacturing spaces.
Learn moreEquipment Qualification
21 CFR Part 11 assessments, computer system validation lifecycle, IQ/OQ/PQ for production equipment, and vendor audits.
Learn moreProcess & Cleaning Validation
Process validation lifecycle, gap analysis, cleaning validation, and swab recovery studies aligned to ICH Q7–Q12 and FDA guidance.
Learn moreQuality Control Labs
Method transfer and validation, chromatography software validation, and cGMP documentation review for QC laboratories.
Learn moreTraining & Documentation Management
Role-based GxP training, SOP authoring and lifecycle management, and documentation systems that pass FDA and EMA inspections.
Learn moreProject Management
Full project lifecycle for regulated facility builds, line transfers, and validation programs — initiation through closeout.
Learn moreImplementation Support
Embedded specialists who execute equipment, system, and platform upgrades inside regulated environments without disrupting operations.
Learn moreReady to talk about your project?
Quality systems, validation, technology, or training — a QRC consultant will follow up within one business day.
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