OUR SERVICES

Facility Design & Layout
We can provide design layout for your specific needs.

• Processing rooms planned with emphasis on
  equipment, and flow of materials and personnel
• Strategically located areas for: 
  • Manufacturing
  • Packaging/Labeling
  • Warehousing

---

Equipment

• Specification
• Selection
• FAT and SAT inspections  

---

Validation
Validation is available for entire systems and facilities
or for smaller projects.

• Equipment and Utility qualifications
• Product and Process validations
• Cleaning validations
• Aseptic processing
• Prepare and execute IQ, OQ, PQ protocols and
  provide summary reports
• Media fills 

---

Technical Documentation

• SOPs
• MBRs
• Change Control Documents
• IQ, OQ, PQ
• Revalidation Protocols
• Validation Master Plan 

---

Preventative Maintenance

• PM for specific systems or individual equipment
• Perform PM
• Personnel training
• Review and recommendation services for existing PM

---

Training & Development

• Use of equipment
• Theory, operation, and PM for freeze dryer
• Administering validation protocols
• Complying with SOPs
• Adhering to PM procedures
• General validation theory
• Change Control Management
• Aseptic Processing 

---

Product Manufacturing

• Trouble shooting
• Process optimization
• Assessment of current and future projects
• Simple formulations
• Emulsions
• Lipids
• Aseptic compounds
• Freeze-dried products 

---

Lyophilization
We can guide you through the entire lyophilization process.

• Equipment and process assessment
• Equipment selection
• Improvement recommendations 

---

Project Management
Cost effective oversight management is available
for entire projects or for individual stages of development.

• Conceptualization/design
• Strategic planning
• Costing
• Construction
• Validation
• Start-up
• Clinical manufacturing
• Commercial manufacturing 

---

Quality

• Quality Assurance
• Quality Control
  • Microbiology
  • Chemistry
• Auditing