Synchrogenix provides global regulatory strategy consulting harnessing all of Certara’s capabilities, and leveraging our technologies and domain expertise Regulatory gap analysis of development programs and global dossiers to increase probability of success for approval and patient access Agency engagement preparation, communications, and leadership Review of Agency correspondence, analysis of relevant regulatory guidelines and precedent Competitor […]

Achieving Regulatory Milestones Having a well-constructed regulatory submission strategy that is interwoven into a sponsor’s operational program is even more critical to achieving success than in the past. Between the escalating competition, speed, cost, and risk; benefit pressures on sponsors; the need for payers to see ‘best-in-value’ data of a drug to justify adding it […]