Solving Clinical Holds with Targeted Toxicology Support


 When a US-based biopharma company faced an FDA clinical hold due to preclinical toxicology concerns, DDReg stepped in.

Our regulatory and toxicology experts conducted a deep-dive review of IND data, identified dose-justification gaps, and developed a scientific response package that led to conditional lifting of the hold.

Result? The sponsor resumed its Phase 2 trial without derailing development timelines or investor confidence.

This case study highlights how expert toxicological insight and regulatory strategy can turn a major obstacle into continued progress.

🔍 Explore the full case study: https://resource.ddregpharma.com/case-studies/fda-clinical-hold-lifted-with-ddregs-toxicology-expertise/

#RegulatoryAffairs #ClinicalTrials #FDA #DrugDevelopment #Toxicology #Pharma #DDReg #RegulatoryStrategy

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