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.