PHARMACO

SERVICES

• Quality system design and implementation to meet GXP, ISO or HACCP

• Provision of customised training courses in GMP

• Sourcing of Plant and laboratory equipment for manufacturing operations

• Liasing with regulatory authorities to get marketing authorisations for product

• Assisting with Regulatory Documentation

• Formulation Research

• Assisting and advising on validation of methods and systems

• Quality system pre-auditing for EU authorities, FDA

• Supplier Qualification

• Plant and cross-plant analysis and benchmarking using Informance Software. System support, installation and training of operators and supervisors in its use.

• LIMS implementation

• Calibration and Validation Management Software. Installation, training and support for ProcalV5.

• Synapse Wireless data aquisition hardware/software for cold room, HVAC, Clean room or Stability chamber. Suitable for Pharmaceutical, Medical, Food Industry, Bloodbanks, Museums, Libraries, Warehousing. Wireless systems can record temperature, humidity, pressure differentials, carbon dioxide, Light Levels or ethylene levels. We provide sales, system support, installation and training of operators and supervisors in its use.

• Statistical Process Control Implementation using the Zontec software system. Sales, system support, installation and training of operators and supervisors in its use.

• QP sign-off