Regulatory Services for Drug Development Programs in the United States

Sofpromed provides regulatory strategy services for biotech and pharma companies working on drug development programs in the United States, including:

• Pre-IND meeting preparation, communication with US-FDA, EMA (end-to end)
• Develop regulatory strategy
• Investigational New Drug (IND) preparation, submission (CBER, CDER)
• eCTD submission to regulatory agencies
• Type A, B, C, EOP1, EOP2, pre-NDA meetings preparation and communication
• Preparation and submission for Orphan Drug Designation (ODD), Priority Review
• Voucher (PRV), Qualified Infectious Diseases Product (QIDP) designation
• Special protocol Assessments (SPA)

Please contact us if you need regulatory strategy services in the United States.