Supplying product to fuel your clinical trials and commercial operations is often a rate limiting task for companies especially the small development company that is becoming commercial.  A robust supply chain organisation is critical to a company’s success.  This is especially true when the manufacturing is outsourced which in itself poses special challenges.

Calcott Consulting has extensive experience from the early R&D phase to supply pre-clinical toxicological studies all the way up to the commercial phase with products selling in the multi-billion dollar range.

Our expertise is broad and includes all of the following:

Supply Chain Logistics

• Clinical manufacturing strategy and execution
• Commercial operations strategy and management
• Life cycle management for mature products
• Supply chain management both internally and via contract manufacturing operations
• Sourcing materials and services
• Developing strategic relationships

Facilities

• Plant design, commissioning / start-up and validation
• Technology transfer especially across multiple time zones and cultures
• Facility / equipment / utility validation strategy
• Effective training and certification programs

Processes

• Process development and First to Human strategy
• Process validation strategy, design and implementation
• Process robustness from process development through commercial operations
• Process optimization
• Quality by Design strategy and implementation

Expert Witness

• Expert witness in litigation related to technical aspects of the business.

Contact us so that we can discuss your needs. We look forward to working with you to implement your strategy and develop new processes and products.