Strategy and Guidance

REGEXBIO can provide general insight and guidance on the CMC development of your biopharmaceutical to ensure that development goals are met. CMC needs for a biopharmaceutical must align with the timeline of First-In-Man, Phase 1, EOP2 etc. but also need to product-specific issues such as definition of a starting material or drug substance. Points to address may be:

• Key CMC regulatory milestones
• 1-year vs. longer term time horizons
• Touch points with other product development groups
• Show stopper issues
• QTPP and CQA assessments

Strategy input is most often provided by interactive meetings (telecon, skype, face-2-face as required) with a follow up report, either in as a regulatory strategy summary or input into a product development plan. Such advice can be provided ad hoc or at regular intervals, depending on client needs.