Our Services
Services
- Development of customized CMC strategies to meet regulatory requirements.
- Expert advice on early process development from Cell bank preparation to GMP final drug product release.
- Product characterization, release, and stability specification definition.
- Guidance through process changes and demonstration of product comparability.
- Expert advice on process development prior to pivotal studies and BLA/MAA submission.
- Preparation of high-quality regulatory documentation (CTD format).
- Deep expertise in both FDA and EU CMC regulatory landscapes.