PHARMACEUTICAL REGULATORY AFFAIRS
Regulatory Gap Analysis
Identification of regulatory deficiencies and practical pathways to dossier readiness.
SERVICE 05
Systematic gap assessment
We compare available dossier and product documentation with applicable regulatory requirements, current guidance and the intended application or maintenance procedure.
Documentation and compliance gaps
An assessment may cover dossier completeness, scientific content, product information, procedural history and the consistency of information across documents.
Remediation planning
We document findings, prioritise remediation according to their potential regulatory consequences and propose proportionate corrective actions, responsibilities and next steps.
Typical support activities
- CTD/eCTD dossier gap assessments
- Marketing authorisation readiness assessments
- Product information consistency checks
- Regulatory compliance risk review
- Prioritised remediation recommendations
Services and deliverables are subject to a project-specific scope of work and the relevant regulatory framework.
DISCUSS A PROJECT
Need specialist regulatory affairs support?
Get in touch to discuss the regulatory scope and documentation requirements for your project.