Regulatory Due-Diligence

Regulatory due diligence activities performed for in and out-licensing opportunities. iReg consulting can evaluate reports and documentation for regulatory compliance in the area of chemistry, manufacturing, and analytical controls and provide an expert review on pivotal questions, gaps in manufacturing and control parameters, assessment of regulatory risk and strategy.

iReg Consulting provides the following services to the pharmaceutical industry for Regulatory Due-diligence

Dossier review for completeness and regulatory history
Dossier review for current regulatory standards
Regulatory authority communication and commitments
CMC gap analysis and remediation strategy
Dossier build for update and missing documents
Dossier compilation for new market entry