Worldwide Clinical Trial Applications (CTA) and Marketing Authorization Applications (North and South America, EU, Asia-Pacific, and Emerging Markets)

Pharmatech offers best-in-class regulatory expertise to ensure that your submissions and agency negotiations proceed as smoothly and effectively as possible. We have experience in each therapeutic area with marketing authorization applications across the globe. In addition to authoring CTD sections, our staff is also experienced at crafting responses to information requests (IRs) from health authorities to address their clinical, CMC, and non-clinical concerns. For markets that require electronic submissions, Pharmatech can prepare and submit your documents in electronic format (eCTD).

United States (FDA)

  • Investigational Product Applications
  • Master Files
  • New Product Applications:
    • Drug: NDA, 505(b)(2), Generic ANDA
    • Biologics: BLA, Biosimilar, Biobetter
    • Devices: PMA, 510(k), De Novo
  • Product Process Changes:
    • Prior Approval Supplement
    • Changes Being Effected (CBE-30)
    • Annual Report
    • Development Safety Update Report

European Union

  • Scientific Advice
  • Clinical Trial Application
  • Investigational Medicinal Products Dossier
  • Marketing Application Authorization
  • Device Technical Files and Design Dossier
  • Clinical Trial Applications for Medical Devices and in vitro Diagnostics
  • Class I, IIa, III Medical Device CE Mark
  • Class A, B, C, and D in vitro Diagnostic CE Mark
  • Post-Market Surveillance Reports

Rest-of-World

  • International Core Dossier
    • Drug: NDA, 505(b)(2), Generic ANDA
    • Biologics: BLA, Biosimilar, Biobetter
  • International Marketing Authorization Submissions
    • China and Japan
    • Gulf Cooperation Council
    • Israel
    • South America and Mexico
    • Australia

Canada

  • Clinical Trial Application
  • New Drug Submission
  • Abbreviated New Drug Submission
  • Drug Identification Numbers
  • Establishment License
  • Medical Device License
  • Investigational Testing Applications
  • Annual Reports
  • Renewal Applications
  • Master Files