From IND to PDUFA

Regulatory Writing

We take your medicinal product from pre-IND through approval

Investigational New Drug (IND) Application Documents

  • Investigator's Brochure

  • Clinical Study Protocols (including clinical trial design)

  • Informed Consent Forms

  • Pharmacology and Toxicology Information

  • General Investigational Plan

  • Annual Reports

  • Safety Reports

New Drug Application (NDA) Documents

  • Common Technical Document (CTD) Modules:

    • Module 2: Summaries

      Quality Overall Summary

      Nonclinical Overview and Summaries

      Clinical Overview and Summaries

    • Module 3: Quality (in close collaboration with CMC experts)

    • Module 4: Nonclinical Study Reports

    • Module 5: Clinical Study Reports

Clinical Study Reports (CSRs)

  • Phase 1, 2, and 3 CSRs

  • Integrated Summary of Safety (ISS) (in collaboration with statisticians and programmers)

  • Integrated Summary of Efficacy (ISE) (in collaboration with statisticians and programmers)

Regulatory Correspondence

  • Responses to FDA Information Requests

  • Meeting Briefing Packages

  • Minutes from FDA Meetings

Product Labeling

  • Package Inserts

  • Medication Guides

  • Patient Information Leaflets

Risk Management Documents

  • Risk Evaluation and Mitigation Strategy (REMS)

  • Risk Management Plans

Periodic Safety Reports

  • Periodic Adverse Drug Experience Reports (PADERs)

  • Development Safety Update Reports (DSURs)

Special Designations and Expedited Programs

  • Orphan Drug Designation Requests

  • Fast Track Designation Requests

  • Breakthrough Therapy Designation Requests

Post-Marketing Documents

  • Annual Reports

  • Supplemental NDAs for new indications or formulations

  • Periodic Safety Update Reports (PSURs)

Advisory Committee Meeting Materials

  • Briefing Documents

  • Presentation Slides

Responses to Complete Response Letters

  • Addressing FDA's concerns and requests for additional information

Miscellaneous

  • Pharmacokinetic and pharmacodynamic data summaries

  • Drug-drug interaction studies reports

  • Bioequivalence study reports for generic small molecule drugs

  • Stability data summaries

  • Impurity profiles and related safety assessments