SERVICES

• 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.