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Pharmaceutical Consulting
Compliance support for laboratories where the result informs a regulatory decision.
In pharmaceutical quality control, data must withstand audit.
We help pharmaceutical laboratories align their procedures, equipment and records with GMP and GLP expectations, so that results are reliable and defensible.
Our work covers the laboratory end to end: methods, instruments, people, documentation and data.
What we do
- GMP and GLP compliance assessment
- Independent review of laboratory practice against applicable GMP and GLP requirements, with a prioritised action plan.
- Analytical method validation
- Validation and verification of analytical procedures in line with applicable pharmacopoeial and regulatory guidance.
- Equipment qualification and calibration
- Qualification and calibration programmes that keep instruments fit for their intended use.
- Data integrity and documentation
- Practices and records that keep laboratory data attributable, complete and reliable.
- Audit readiness
- Mock audits, corrective and preventive action support and preparation for client and regulatory inspection.
- Laboratory review and layout
- Review of quality control laboratory layout, flow and controls.
How we work
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Assess
We review the laboratory against applicable requirements.
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Prioritise
Findings are ranked by risk and an action plan is agreed.
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Remediate
We support procedures, validation, qualification and training.
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Verify
A follow-up review confirms the actions are effective.
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Sustain
Your team is equipped to maintain compliance.
What you can expect
- Procedures and records aligned to GMP and GLP
- Validated, defensible analytical methods
- Instruments qualified and calibrated for their intended use
- A laboratory ready for client and regulatory audit
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Speak with a Mavelin consultant. Tell us what you are working towards and we will respond with a clear next step.