Critical Consistency
Accelerate the development, approval, and lifecycle management of your biopharmaceutical products through understanding and control. Many companies in the Berkshire and Thames Valley region face challenges in developing the detailed knowledge needed to consistently produce and control biopharmaceutical products according to quality standards.
Leveraging our extensive experience and expertise in CMC and manufacturing, gained from both industry roles and supporting biopharma companies across Berkshire, we apply this knowledge across multiple modalities and manufacturing platforms to enhance and accelerate your product's success. Our methods also support AI-based product development approaches.
Process Development Solutions in Berkshire
Chemistry, Manufacturing, and Controls (CMC) encompasses all activities and documentation required to ensure a pharmaceutical product is consistently produced and controlled. Our multi-disciplinary team provides comprehensive support to ensure products meet quality standards, leveraging Quality by Design (QbD) principles and extensive knowledge of ICH guidelines.
GMP Compliance and Regulatory Support in Berkshire
Good Manufacturing Practice (GMP) ensures manufacturing processes meet quality standards. We can help your Berkshire-based company with documentation, validated procedures, and personnel training to maintain compliance and data integrity.
Process Characterisation and Scale-Up for Local Companies
We assist companies across the region with Process Characterisation and Process Scale Up. During development, a process needs to be taken from small-scale to full commercial scale while maintaining performance. We help you retain process consistency and compliance, preparing you for PPQ readiness.
Clinical and Commercial Supply for the Berkshire Hub
Supplying material for late-stage clinical trials & commercial distribution requires validated and robust processes. We help ensure efficient, batch-to-batch consistency that complies with global standards, enabling reliable production and timely supply of product for our clients in Berkshire and beyond.
Why Partner with GreyRigge Associates in Berkshire?
- Global expertise, delivered locally – offices in the UK, USA, and Japan
- Practical, agile solutions that accelerate progress without overcomplication
- Proven track record supporting biopharma companies of all sizes
- Integrated partnership model – we work side by side with your teams
Ready to strengthen your CMC and manufacturing capabilities in Berkshire?
Contact GreyRigge Associates today to discuss how we can support your programme.