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From clinical phase to the final registration and beyond during the commercial manufacturing, Peptisyntha provides you all required regulatory support for your API.
- Process validation
- Development and validation of the testing methods
- Reference standard qualification
- Impurity characterization
- ICH stability studies
- All documentation required for your IND/IMPD or NDA/MAA filings
- CMC and DMF compilation will be provided and maintained by continuous updates
- Annual Product Reviews
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