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Our Services
01.1. GMP Risk and Compliance
Our GMP Risk & Compliance Oversight service provides structured, evidence-based cGMP and contamination control assessments across your sterile, non-sterile, ATMP, oral solid dose, medtech and cosmetics operations. We help you identify risks before they escalate and ensure your systems, processes and controls meet EU GMP, FDA CFR, Annex 1 and ISO expectations prior to or after an inspection.
02.2. Design, CQV and Validation
Our Design, CQV and Validation service delivers robust, data-driven qualification of facilities, utilities, equipment and processes across sterile, non-sterile, ATMP, oral solid dose and cosmetics operations. We help you achieve compliant, inspection-ready systems by aligning validation activities with EU GMP, FDA CFR, Annex 1 and ISO expectations throughout the full project lifecycle.
03.3. Contamination Prevention
Our Contamination Prevention service applies a proven approach to Contamination Control Strategy development supported by CPD Certified training across sterile, non-sterile, ATMP, oral solid dose and cosmetics operations. We help you reduce microbiological and particulate risks by strengthening controls, behaviours and monitoring practices to meet EU GMP, FDA CFR, Annex 1 and ISO expectations.
04.4. Operational & QMS Readiness
Our Operational Readiness service ensures your people, processes and Quality Management System are prepared for reliable manufacturing across sterile, non-sterile, ATMP, oral solid dose and cosmetics operations using our proven tools and templates. We help you achieve consistent performance by deploying SOPs, training, engineering controls and start-up support aligned with EU GMP, FDA CFR, Annex 1 and ISO expectations.
05.5. Regulatory Preparation + Launch
Our Regulatory Readiness and Product Launch service provides structured, evidence-based support with mock audits and inspection preparation across sterile, non-sterile, ATMP, oral solid dose and cosmetics operations. We help you achieve smooth approvals by aligning documentation, validation summaries and compliance records with EU GMP, FDA CFR, Annex 1 and ISO expectations.
06.6. GMP Remediation
Our GMP Remediation and Quality Systems service provides targeted, evidence-based correction of compliance gaps across sterile, non-sterile, ATMP, oral solid dose and cosmetics operations. We help you stabilise quality performance by strengthening processes, documentation and governance to meet EU GMP, FDA CFR, Annex 1 and ISO expectations.