Development & Strategy Regulatory Submissions & Applications

Regulatory Submissions & Applications

CTI’s has continued proven success in numerous approved drug and device applications. We regularly prepare international regulatory submissions, including:

  • 510(k) premarketing submission
  • Biologic License Application (BLA)
  • Clinical Evaluation Reports (CERs)
  • Pre-Investigational New Drug (Pre-IND)
  • Investigational Device Exemption (IDE)
  • Investigational New Drug (IND)
  • New Drug Application (NDA)
  • New Drug Submission (NDS)
  • Pediatric Investigation Plan (PIP)
  • Premarket Approval Application (PMA)
  • Risk Evaluation and Mitigation Strategy (REMS)
  • Supplemental Biologic License Application (sBLA)
  • Supplemental New Drug Application (sNDA)
  • Systematic Literature Reviews

Kathy Wekselman, PhD, RN
Senior Director, Regulatory & Scientific Affairs
Kathy has extensive global experience in strategic drug development planning, clinical protocol development and execution, interactions with regulatory authorities, and development and submission of regulatory documents. She has nearly 40 years of clinical, industry, and academic experience, including 10 years spent in nursing.

Kathy Wekselman

Our team members can electronically submit all applications to regulatory agencies around the world by utilizing electronic-Common Technical Document (eCTD) software. Each deliverable includes expertise from our diverse team of regulatory, trial operations, data management, biostatistics, medical affairs, medical writing, and publishing experts. Throughout the development process, we use regulatory accepted document templates, programs, and processes to produce compliant regulatory submission documentation, reports, and dossiers. We have an independent Quality Assurance team that ensures quality is the leading factor in all of our services and is reflected in all of our submissions to regulatory authorities. 

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