Consulting Services for the Pharmaceutical & Medical Device Industries

We provide services on either an hourly-rate basis, or at a fixed price either on-site or remotely. With over 10 years experience in the Pharmaceutical & Medical Device Industries we can work under your direction at short notice for both short or long duration projects.

• We can assist in writing Technical Document and Test Scripts.
• We can also provide generation and review service for the creation of validation documentation with regards to laboratory equipment installations and laboratory software implementations including CDS and LIMS.
• We can assist with the generation and review of GLP/GMP Quality Management Systems or Quality Management Systems documentation.
• We can assist with performing and the generation of both on and off site audits.
• We can assist with performing and the generation of risk assessments.
• Improvemenst to your current laboratory systems and quality systems.
• Coordination of software validations.
• Generation of training plans and performing training modules.
• Spreadsheet and database creation and validation.
• Perform and review 21 CFR Part 11 and Annex 11 compliance to FDA/EU requirements
• We can assist with performing and the generation of Management Systems Policies, SOP and Forms.
• We can assist with the generation, performance and review of business contingency plans or disaster recovery plans.

We can assist with the review of new technology feasibility studies and vendor assessments.

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