USA: +1 617 939 9497 | UK: +44 2039 962936 | EU: +34 607 939 266 info@sofpromed.com
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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.

Contact us to request more information or get a quote

US: +1 617 939 9497

 UK: +44 2039 962936

EU: +34 607 939 266

info@sofpromed.com