Regulatory Compliance & Support
Ash Stevens is a fully cGMP-compliant operation offering regulatory support spanning early-stage drug substance development through NDA registration and post-approval manufacturing.
We have an exemplary history of successful inspections by regulatory agencies worldwide that include the European Union, Australia, Japan, Korea and Mexico. We are experts in the preparation of regulatory filing documentation according to current standards. Whatever your development strategy and/or target market, Ash Stevens can provide the appropriate and timely regulatory support.
Regulatory Services Include:
- Licensed FDA cGMP-compliant facilities
- Preparation of development documentation
- Maintenance of robust SOP documentation
- Preparation of registration documents according to FDA and CTD standards
- Generation of master production records
- Development of specification for all materials, intermediates and API cleaning documentation
- Maintenance of a sample retain program
- API stability support
- Process Validation and Technology Transfer support
- Generation and maintenance of DMFs, when requested
- Annual Product Reviews for all commercial products and others as requested