The easiest inspection is the one you’re ready for.
Our Services
Independent audit and regulatory compliance support for regulated industries.
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Description:
Independent audits to support supplier qualification, risk management, and ongoing compliance oversight across global supply chains.Scope includes:
API and drug substance manufacturers
Contract manufacturers (CMOs/CDMOs)
Contract laboratories and CROs
Raw material and component suppliers
Packaging, labeling, and distribution vendors
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Description:
Preparation for regulatory inspections through structured assessments aligned with current FDA and global regulatory expectations.Services include:
Mock FDA inspections
Pre-Approval Inspection (PAI) readiness
Gap assessments
Inspection strategy and preparation
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Description:
Support following regulatory observations to strengthen compliance and prevent repeat findings.Services include:
Root cause analysis
Corrective action planning
Regulatory response support
Ongoing readiness improvement
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Description:
Evaluation of quality systems to identify compliance gaps and improve effectiveness across key processes.Areas reviewed:
CAPA systems
Deviations and investigations
Change control
Documentation and SOPs
Data integrity practices
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Description:
Onsite or remote audits of manufacturing and laboratory operations to assess compliance with GMP, GLP, and GCP expectations.Scope includes:
GMP manufacturing operations
Analytical and microbiological laboratories
Bioanalytical labs
GLP and GCP environments
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Steps:
Initial discussion to define scope and objectives
Audit or assessment conducted onsite or remotely
Detailed report with observations and recommendations
Optional follow-up support for remediation or readiness
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