Three ways we partner with you. From quality system development to validation lifecycle management and clinical sponsor support, every engagement is built around your specific needs, not a generic template.
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.
QMS framework design and implementationDeviation and CAPA management programsRisk management programsSOP and procedure developmentChange control systemsManagement review processes
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.
GMP training program developmentAnnual GMP compliance trainingLeadership coaching and accountabilityOnboarding and refresher trainingRole-specific content customizationContinuous improvement workshops
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.
Root cause investigation leadershipInvestigation report drafting and reviewEffectiveness checks and follow-upOOS / OOT investigation supportCAPA plan developmentStaff mentoring and capability building
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.
Internal audits (onsite or remote)FDA 483 and Warning Letter remediationQuality Agreement developmentSupplier and CDMO auditsCDMO qualification managementLive FDA inspection support
Review and support documentation for validation, stability, specifications, and batch records, ensuring alignment with GMP and company standards across all regulatory deliverables.
Batch record review and oversightSpecification review and developmentQuality Agreement preparationStability documentation supportValidation documentation reviewRegulatory deliverable management
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.
Cleanroom design review and qualificationFAT / SAT witnessing and coordinationRisk-based qualification strategiesUtilities, HVAC, water systems (WFI / PW)IQ / OQ / PQ protocol developmentTraceable summary reports
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.
Process validation plan developmentProduct performance validation (PPQ)Regulatory compliance data summariesSIP / CIP development and validationAseptic process simulation (media fills)CPP and CQA definition and verificationContinued process verification (CPV)Cleaning Validation
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.
Validation Master Plans (VMPs)Functional and Design SpecificationsDeviation investigation and resolutionUser Requirements Specifications (URS)Protocol execution and data analysisLifecycle requalification support
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.
GAMP 5 risk-based CSV methodologyBuilding automation system (BAS) CSVIQ / OQ / PQ protocol developmentLIMS, MES, EBR system validation21 CFR Part 11 compliance assessmentElectronic records and signatures review
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.
Controlled room temperature mappingIncubator and stability chamber mappingHot/cold spot risk assessmentRefrigerator and freezer qualificationShipping qualification studiesSeasonal revalidation programs
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.
Phase-appropriate SOP developmentData integrity procedures and oversightCMC support through tech transferDrug substance and drug product specificationsGlobal GMP / GCP complianceScale-up of GMP manufacturing
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.
CDMO qualification audits (onsite & remote)Batch record review and approvalTemperature excursion managementQuality Agreement developmentDeviation and CAPA reviewCoA and Certificate of Release issuance
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.
IND / ANDA drafting and reviewInvestigator Brochure quality reviewCRO / CMO GCP compliance oversightDSUR and annual report reviewClinical protocol and Pharmacy Manual reviewRegulatory audit support at clinical sites
Pages built around the specific problems teams search for.
Risk-ranked remediation when observations have already been issued.
Strategy, gap assessments and documentation support across FDA requirements.
GMP and inspection support for registered outsourcing facilities.
Real partnerships delivering sustainable solutions across pharmaceutical and biotech development.
Amicus stepped in during a challenging FDA 483 remediation and worked right alongside our team. Their practical approach and deep knowledge of quality systems helped us resolve observations and strengthen our processes for the long term.
VP Quality AssurancePharmaceutical Manufacturer
The validation support from Amicus was excellent. Their team brought real-world CQV experience that helped us commission our new facility on schedule while staying aligned with our validation master plan and regulatory expectations.
VP Technical OperationsCDMO
Amicus provided hands-on support as we scaled our manufacturing operations. Their consultants worked closely with our team to improve documentation, refine procedures, and ensure our systems aligned with cGMP expectations.
Head of ManufacturingBiotech Company
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.