Consultancy

We have established a consultation philosophy based on sensible, scientific solutions to the complex problems which face our industry.

Our consultation approach involves a blend of science and engineering, practical and theoretical, which affords us a flexibility and perspective that most companies do not have.

With industry experienced scientists and engineers, as well as a full-service architectural department, we can bring unique options to any project. Our efficient team, who are recognized leaders in their fields of expertise, stay abreast of technological and regulatory trends so that we can offer you practical solutions which meet federal and international regulations and guidelines.

Our broad range of services includes:

• Confidential Audits
• Quality Manuals
• Process Mapping
• Training Programs
• Validation Master Plans
• Drug Master File Audits
• Transfer of Technology Programs
• Environmental Monitoring
• AIP Issues, Investigations and Remediation Plans
• Sterilization Processes
• Expert Witness
• Design Review
• Facility Master Plans
• Pre-Approval Inspections
• GMP and GLP Compliance Audits
• Process Development
• Aseptic Filling

We value the partnerships created when we begin a new project. Your success is our top priority. Most of our business comes from repeat customers - a real source of pride and sign of our achievement. We realize the need to balance your regulatory and business concerns and we work with you to identify and implement solutions which optimize your resources.