- Preparation of Global regulatory strategies
- Manufacturing site rationalisation (site transfers)
- International CMC variations
- EU Post Marketing Applications
- Authoring Module 3 documentation
- CMC authoring experience with drug products and drug substances
- Ensuring compliance with current regulatory requirements and standards
- Gap analysis and Compliance projects
- Review of CMC data
- Responding to regulatory authority questions
Meeting your requirements either on-site or remotely.
To discuss any other requirements you may have, please get in touch.