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• Quality system design and implementation to meet GXP or ISO


• Computer System Validation


• Data Integrity Audits and remediation


• Lead auditor pre-inspection and remediation


• Mock audits in preparation for FDA or EU inspections


• Contracted staff to cover 3 - 12 month periods


• Customised training courses


• Design of compliant Food, Feed or Medicinal facilities and associated manufacturing systems


• Facility Validation


• Advice on the relevant laboratory testing to comply with relevant legislation


• Sourcing of Plant and laboratory equipment for manufacturing & Laboratory operations



• Assisting with Regulatory Documentation for Medicine submission.



• Assisting and advising on the validation of methods and systems for Medicines.


• Technology and method transfers


• Validation of new or updated systems


• Project Management

• Contracted Chemical and Microbiological Analytical Services


• Hardware and Software system implementation for Process Control and Temperature/ Humidity Monitoring.

• Formulation and Product Development for Food, Feed and Medicines.





Are you ready for your next FSA, DARD, HPRA, MHRA, VMD or FDA audit?