Process By Design CMC Consulting, LLC

Believer through experience that fundamental QbDs define CMC success. A process is by design. Services include: - Early Strategic Advice - building foundation for success establishing approach from early candidate nomination forward - Process Development - provide guidance on establishing early small scale approach and quality attribute methods with targets for success - Process Scale-up - provide scalable platform assessment and feedback. Supporting equipment selection and implementation. Early raw material suitability and sourcing. - Manufacturing - planning and execution support from tech transfer kickoff through drug product release