Problem:
1. How do you design a facility when the process is still under development?
2. What is Process Analytical Technology all about?
3. What are the right design, operating, and maintenance tactics?
4. How do you model complex bio-pharmaceutical processes?
5. Is your company ready to take advantage of new bio-pharmaceutical regulatory initiatives?
6. How do you transfer technology quickly and efficiently?
7. How do you address business, operating, or compliance shortfalls with existing manufacturing operations?

Solution:
1. Commissioning Agents Technology Implementation Group
2. Experience and know-how.
3. Practical solutions to complex problems.
4. Knowledge-based, not theory-based.
5. Synchronizing process science, manufacturing technology, engineering, management, business objectives, and regulatory compliance.

6. Commissioning Agents Technology Implementation Group consists of seasoned manufacturing professionals: engineers, scientists, quality and regulatory experts, who develop and help implement practical solutions to your manufacturing problems. From initial user requirements and conceptual design studies, to process capability studies and modeling, to manufacturing trouble-shooting, we bring decades of experience, a hands-on approach, and a tenacious attitude.

Major Services
Process Improvement

• Process Analytical Technology (PAT)
• Process modeling (y1, y2, y3...) = f(x1, x2, x3...)
• Process characterization packages
• Technology transfer (planning, project management)

Facilities Engineering

• User requirements
• Facility programming/basis of design
• Functional design reviews
• Maintenance programs
• Training programs

Compliance (biotech/pharmaceutical industry)

• Mock audits
• cGMP compliance remediation
• Comparability protocols
• Preparation/review of NDA/ANDA and supplements
• Risk-based approach to validation, using Quality by Design concepts
  

Business and Manufacturing Management

• Business and manufacturing modeling and improvement
• Project management
• Project reviews