Our “Compliance Consulting” team specializes in helping pharmaceutical firms establish efficient, cost effective quality systems that will pass inspection and produce high quality products.  We also review current systems to make them more efficient and robust enough to stand up to current regulatory challenges. 

• Management: We assist with management strategies, tailored for companies that want to set up the most cost effective and efficient compliance infrastructure possible with limited resources.
• Auditing:  We perform all types GMP Audits and provide a very detailed, specific report of recommended actions, including full references to the pertinent regulations and guidance documents.
• Quality Systems: We review, implement or improve any Quality System, including all those for QA, Manufacturing, Laboratories, and support groups.
• Process Validation: We set up a process validation program that will pass inspector scrutiny, everything from writing the SOPs and Master Plans to writing and executing the protocols and summarizing the data into usable reports.
• Computer Validation: We help develop Master Plans, SOPs, and protocols required to make sure your systems are fully validated and compliant with PIC/S, WHO or US FDA (21 CFR Part 11) requirements
• Facility Monitoring: We review your current Facility Monitoring program to ensure it is robust enough to pass inspection.  We can help you analyze locations that show frequent excursions for how to correct the situation.  We can also analyze data, create trend reports, and write validation protocols.
• Utility Monitoring: We can review your current Monitoring programs for water, steam, and plant supplied gases to ensure they are robust enough to pass inspection.  We can help you analyze use points that have had frequent excursions for how to correct the situation.  We can also analyze data, create trend reports, and write validation protocols.
• Training: We bring training programs to your site and we offer several courses a year at various international sites.

2. TECHNOLOGY CONSULTING

We help our clients develop information technology strategy and processes that work.  The integration of timeless manufacturing principles with 21st century information technology produces astonishing results.