Regulatory submissions are high-stakes documents. Every word must be accurate, every section must be complete, and every claim must be defensible. At Craft Science Inc., we support drug development teams (sponsor-led and investigator-led trials) with regulatory writing that is precise, compliant, and strategically structured to support the full clinical development lifecycle.
We support Health Canada Division 5 and FDA clinical development documents for sponsor-led and investigator-led trials, across the drug development lifecycle:
Supporting New Drug Applications (NDAs), New Drug Submissions (NDS), Abbreviated submissions (ANDAs/ANDS) through quality review & strategic advice
A well-written protocol is the foundation of a successful clinical trial. Under ICH E6(R3), it must do more than describe procedures. It needs to articulate critical-to-quality factors, risk-based oversight, and patient-centric design considerations.
We develop ICH-GCP-compliant study protocols for Phase I through Phase III trials, protocol amendments, Informed Consent Forms (ICFs), patient-facing materials and documentation required for Institutional and Ethics Review Board (REB/IRB) submissions.
We conduct targeted pre-clinical/clinical literature reviews and clinical gap analyses:
Regulatory inspections reward preparation. Drawing on CCRP-level expertise in clinical trial operations, we help sponsors and sites clear documentation backlogs, close compliance gaps, and prepare for Health Canada/FDA audits:
We support on-going trials by translating complex safety data into clear, compliant, and traceable documentation:
Patient safety narratives are a critical part of Clinical Study Reports (CSRs) per ICH E3 (Sections 12.3.2/14.3.3). We develop individualized patient narratives providing clinical context for SAEs and significant events across all trial sites, supporting transparent safety evaluation and audit-ready documentation.
Working with Health Canada or the FDA? Let’s talk about your submission timeline.