Services
Our Services
Biocontamination Control
We provide a cost effective and flexible range of services to align and support your business needs.
Bespoke training modules covering subjects such as
Bespoke training modules covering subjects such as
- Quality Risk Management
- Understanding biocontamination and its sources
- Performing microbiological risk assessments
- Effective environmental monitoring programmes
- Investigating contamination excursion events
- Choosing the right disinfectants
- Understanding how to clean effectively
We can support this training through on-site operator mentoring to fully align with your operational process.
We can offer on-site support to investigate the root cause of biocontamination events and implement robust process improvements to reduce the risk of future excursion events.
Organisational Development
We can provide you with a clear process map of your current operational system, and using this starting point as a solid foundation upon which to build your process improvements, and ultimately drive towards sustainable growth of your business. We can generate a project plan with clear milestones and realistic timelines to navigate towards the end goal, and provide clarity on the resource requirements to implement the change. We can establish the best tools aligned to your individual business to define the most useful metrics to accurately measure the success of the improvement being implemented.
Project Management
We provide a flexible and tailored project management service for your business needs within the pharmaceutical and biopharmaceutical industries. We understand the challenges of navigating your project through external CRO/CMO facilities and together with the scientific experience to support and manage your projects for release to clinic, we are here to help facilitate this process for you.
Services include:
• Project assessment
• Timeline management
• Method transfer management
• CMO / CRO management
Services include:
• Project assessment
• Timeline management
• Method transfer management
• CMO / CRO management
Quality Management Systems
With extensive experience working in highly regulated environments, we can offer a range of services to support your internal and subcontracted processes.
Services include:
- Review and audit of Quality Management Systems to GLP, GMP and ISO 9001
- Internal and 2nd Party audits
- Manufacturing and Testing Laboratory audits
- Supplier evaluation audits