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From quality system development to validation lifecycle management and clinical sponsor support — every engagement is built around your specific needs, not a generic template.
Amicus Quality Consulting partners with pharmaceutical companies, suppliers, and CDMOs to build adaptable, compliant, and effective quality systems that ensure product integrity and operational excellence.
We meet clients where they are, whether developing foundational quality systems from the ground up, remediating gaps, or preparing for inspection readiness.
Design and implement fit-for-purpose QMS frameworks aligned with FDA, EU, BOPs, and internal expectations. We develop and harmonize SOPs and procedures that work in practice, not just on paper.
Develop and deliver targeted GMP-compliant training programs customized to organizational roles and maturity. We facilitate workshops that embed a proactive, continuous improvement mindset across teams.
Lead and support root cause investigations for deviations, OOS/OOT events, and nonconformances. We mentor staff to enhance internal problem-solving capability — building lasting competency, not dependency.
Perform internal and supplier audits per FDA, EU, and BOP requirements. We provide FDA inspection preparation, live audit support, and full remediation planning — not just audit findings.
Review and support documentation for validation, stability, specifications, and batch records, ensuring alignment with GMP and company standards across all regulatory deliverables.
Amicus Validation services help clients design, commission, and validate equipment, facilities, and systems that ensure compliance, performance, and product safety.
Whether launching a new facility, expanding operations, or remediating existing systems — we design practical, resource-conscious validation strategies that support inspection readiness.
Support facility design reviews and qualification of cleanrooms, utilities, HVAC, water, and process systems. We lead commissioning, qualification, and validation activities with traceable, defensible documentation.
Develop and oversee process development and validation plans, including aseptic process simulation and product performance validation. We define CPPs and CQAs, then verify them rigorously.
Create and maintain validation master plans, URSs, FS/DS, studies, protocols, and summary reports. We execute protocols, analyze validation data, and support ongoing monitoring and improvement programs.
Validate computer systems and software per FDA 21 CFR Part 11 and industry standards, using a GAMP 5 risk-based approach to focus effort where it matters most.
Map temperature and humidity of controlled spaces and equipment. Execute shipping studies for controlled transportation, identify hot/cold spots, and recommend remediation for out-of-spec conditions.
Amicus Clinical Development Support partners with sponsors to build compliant, phase-appropriate quality systems that drive clinical development and ensure data integrity.
We meet sponsors where they are, ensuring GMP and GCP compliance and helping successfully get IMP to clinical sites — acting as an extension of your team at every stage.
Draft, implement, and manage phase-appropriate SOPs for clinical sponsors. We establish specifications for drug substance and drug product, and collaborate with Clinical and Regulatory teams to ensure global compliance and data integrity.
Perform CDMO qualification audits and implement Quality Agreements. We review and approve CDMO-generated documents, oversee stability programs, and issue Certificates of Analysis and Certificates of Release.
Collaborate with technical SMEs to draft and review IND/ANDA submissions. We conduct quality review of DSURs, clinical documents, and amendments, and interface with CRO and CMO to promote GCP compliance throughout trials.
Real partnerships delivering sustainable solutions across pharmaceutical and biotech development.
Let's discuss how Amicus can support your organization's compliance, validation, and quality objectives. Whether you're launching a new facility, remediating FDA findings, or building quality systems—we're here to help.
Let's discuss how Amicus can support your compliance, validation, and quality objectives—from new facilities to FDA remediation.
Tel : (803) 839-0202
Address : 1122 Lady St 3rd floor, Columbia, SC 29201, USA
Business Hours : 8.00 AM to 5.00PM