Whichever service level you chose, Synergy provides full governance. The senior team has a strong background in industry and understands the technical specifications for each workflow. We typically create a governance structure that addresses key stakeholder information at point of need.
Our teams are multi-functional and by introducing a programme of engagement and development it means we can promote from within and extend the team to maximise skillsets.
Typically, we focus on providing the following comprehensive services across the biological development cycle, bioanalytics, and product chemistry functions.
- Formulation and product chemistry
- Method development and validation of testing
- Analytical methodology – large and small molecule
- Stability testing of clinical supplies for drug substance and drug product
- Set-up and analysis of finished product stability samples
- Finished goods testing
- Excipient, packaging, and post-packaging support
As well as a holistic approach to manufacturing functions
- Bulk organic synthesis
- Complex conversions from raw to intermediate product and then from intermediate product to finished good
- cGMP procedures and safe handling techniques
- GMP batch records, label documentation, check sheets, change control, and lab notes
- Maintenance of mechanical and processing equipment to GMP compliant maintenance programmes
- Support all operations via first to third shift schedules
- Generate, manage and report on operational performance data