Professional Know-How

In the highly regulated pharmaceuticals and health sciences sector, there is no margin for error and no room for compromise on the standards for quality, safety and efficacy. Process deviations can be costly and damaging. Every operational aspect must be clearly defined, controlled, verified and documented. Systems must be structured and aligned. Personnel highly trained.

The Benchmark Quality Systems team of industry professionals possess many years of hands-on experience in the daily operations of world class pharmaceutical facilities, with a broad skill set extending across the spectrum of product manufacture, including topical, liquid, solid dose and sterile injectables.

Being fully conversant in the application of the code of Good Manufacturing Practice (cGMP) and the specific requirements of the major regulatory agencies (TGA, FDA, EU), our team of specialists can offer subject matter expert advice and assistance with:

• Regulatory Affairs

• Quality Systems Development and Implementation

• Engineering, Project Management, Process Design and Facility Design/Construction

• Validation and Verification of Systems, Processes and Equipment

We understand that selecting a trusted and experienced technical partner is crucial to ensure successful and efficient delivery of your project with full compliance.

Developing and maintaining an excellent client-partner relationship is the cornerstone of our philosophy. Whether start-up or established, the Benchmark Quality Systems approach will ensure that your project scope and outcomes are clearly defined and understood. From project commencement until completion and handover, transparent communication of all project aspects is assured, as is the availability of Benchmark Quality Systems team members for progress updates and consultation.

Without obligation and with full confidentiality, we welcome the opportunity to discuss how our professional capabilities can support your project.