What We Do
Technical Writing
- Preparation of GMP/GLP SOPs for all laboratory activities through to archiving
- Preparation of validation protocols: analytical, stability, process and cleaning
- Preparation of technical transfer protocols
- Preparation of dossier for Active Substance Master File Procedure
- Preparation of stability protocols to current requirements for all climatic zones
- Preparation of analytical reports: stability studies, batch analysis, validation reports
- Development and upkeep of project plans for all development and scale up activities
Regulatory and Technical Support
- Technical support to industry in all aspects of CMC (Quality)
- Gap Analysis of dossiers and data
- Sourcing of active substances using established contacts and sources
- Preparation of Expert Reports and Quality Overall Summaries
- Advisory service for formulation studies and troubleshooting technical issues/reformulation
- Can lead from preformulation, through development pharmaceutics, 10% batches and onto full commercial batches
- Troubleshooting of all analytical issues with particular emphasis on chromatographic procedures and solid phase extraction
- Assisting with technical transfer from guidance to project leadership