Our Services
A proven methodology to embed cGMP Compliance and Contamination Control from Start to Finish.
Learn more about our Service below
1
GMP Risk and Compliance
Our GMP Risk and Compliance service delivers structured, evidence-based assessments to identify early GMP, Annex 1 and contamination control risks across sterile, non-sterile, ATMP, oral solid dose and cosmetics operations.
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We help you strengthen compliance and prevent future regulatory issues by aligning risk with EU GMP, FDA CFR, Annex 1 and ISO expectations throughout the full manufacturing lifecycle.
2
Design, CQV and Validation
Our Design, CQV and Validation service delivers robust, oversight of design and 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.
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.
4
Operational Readiness
Our Operational Readiness service ensures your people, processes and systems are prepared for reliable manufacturing across sterile, non-sterile, ATMP, oral solid dose and cosmetics operations.
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.
5
Regulatory Readiness
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.
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 manufacturing site quality performance by strengthening processes, documentation and governance to meet EU GMP, FDA CFR, Annex 1 and ISO expectations.