Standard operating procedures
GMP/GLP-compliant SOPs for every laboratory activity, from experimental setup through to archiving.
- Analytical method development SOPs
- Validation and process documentation
- Laboratory operations and archiving
Services
Technical writing, regulatory support and analytical expertise for the veterinary pharmaceutical industry.
Validation protocols
Validation documentation aligned to current international standards.
- Analytical method validation
- Process and cleaning validation
- Stability protocols
Technical transfer and dossiers
End-to-end support for product transfers and regulatory submissions.
- Transfer protocols for development and scale-up
- Active Substance Master File compilation
- Batch analysis, stability and validation reports
- Project plan development and maintenance
CMC and regulatory consultancy
Chemistry, Manufacturing and Controls guidance from concept to commercialisation.
- Formulation design, troubleshooting and reformulation
- Gap analysis, Expert Reports and Quality Overall Summaries
- Sourcing of active substances through global contacts
- Chromatographic and solid-phase extraction troubleshooting
Not sure which of these you need?
Describe the problem rather than the deliverable. We will tell you what the work actually involves, and say so plainly if it is not something we should take on.