GMP Compliance & Remediation
Identify quality-system gaps and develop a practical path toward sustainable improvement. Support may include compliance assessments, remediation strategy, deviation and investigation review, CAPA assessment, effectiveness checks, and follow-up on regulatory observations.
Auditing & Supplier Quality
Gain an independent view of systems, sites, suppliers, and contract manufacturing partners. Support may include GMP audits, supplier and CMO audits, internal audits, due diligence, supplier qualification, audit-program design, and mock inspections.
Validation & Qualification
Plan and execute validation and qualification activities that support reliable, controlled operations. Areas may include processes, cleaning, equipment IQ/OQ/PQ, facilities, utilities, methods, products, laboratories, and cleanrooms, as well as computerized systems validation.
Laboratory & Microbiology Development
Develop and strengthen laboratory operations and microbiology programs. Support may include microbiology laboratory development, laboratory systems, environmental monitoring, method implementation, laboratory qualification, and contamination-control strategy.
Sterile Manufacturing & Aseptic Processing
Support quality and sterility assurance across sterile and aseptic operations. Experience includes cleanrooms, environmental monitoring, contamination control, isolators and RABS, Blow-Fill-Seal operations, visual inspection, and sterile-manufacturing quality systems.
Regulatory & Inspection Readiness
Help your organization assess readiness and prepare for health-authority inspections. Support may include readiness assessments, mock inspections, evidence and document preparation, inspection-response support, remediation, and follow-up.
Data Integrity & Computerized Systems
Assess data-integrity and governance practices across laboratory and manufacturing systems. Support may include forensic data-integrity audits, ALCOA+ assessments, audit-trail and metadata reviews, data-governance programs, and computerized systems validation.
Quality Systems & Operational Excellence
Strengthen the systems that support consistent quality decisions and execution. Areas may include deviations, CAPA, change control, management review, risk management, SOPs and policies, quality governance, quality agreements, and system improvement.
