Regulatory Submissions
CyberGXP helps organisations secure regulatory submission environments so data remains accurate, traceable, and defensible under regulatory scrutiny.
Regulatory submissions represent one of the most critical and scrutinised points in the pharmaceutical and healthcare lifecycle.
At this stage, years of research, clinical data, and manufacturing evidence are consolidated and submitted to regulators for review. Any compromise to data integrity, system security, or availability can delay approval, trigger regulatory findings, or undermine confidence in the submission.
What You’re Protecting
During Regulatory Submissions
Regulatory submission systems contain highly sensitive and business-critical information that must remain controlled throughout the review process.
Key assets include:
Clinical study reports and supporting datasets
Manufacturing and quality documentation
Validation evidence and system records
Regulatory correspondence and submission portals
Submission version control and audit trails
These systems must support confidentiality, integrity, and availability throughout submission, review, and approval.
Cyber Risks at the
Submission Stage
Cyber risk intensifies during regulatory submissions due to heightened access, tight timelines, and increased external interaction.
Common risks include:
Unauthorised access to submission data or portals
Data integrity issues caused by poor access control or logging
Loss of version control or submission traceability
System outages during critical submission windows
Insufficient audit evidence to support regulatory review
Even minor cyber issues at this stage can result in questions, delays, or rejection.
How CyberGXP Secures Regulatory Submissions
Our approach is designed to support regulatory confidence under pressure.
CyberGXP supports regulatory submission environments through:
Regulatory system and data risk assessments
Secure access controls for submission teams and partners
Assurance of submission platforms and document repositories
Audit trail and logging validation
Incident readiness during critical submission periods
Support for regulatory inspections and queries
We focus on controls that protect submission integrity without disrupting regulatory timelines.
Regulatory & Compliance Expectations
Regulators expect organisations to demonstrate that submission data is complete, accurate, and protected against unauthorised change.
CyberGXP supports alignment with:
GxP and data integrity principles (ALCOA+)
Annex 11 and 21 CFR Part 11 requirements
Secure document management and record retention
Audit trail completeness and traceability
Inspection and regulatory review readiness
Cyber security at this stage is inseparable from regulatory compliance.
Reducing Approval Risk
A delayed approval is far more costly than a cyber programme executed properly. Cyber security failures at the submission stage can undo years of investment and preparation.
CyberGXP helps organisations reduce cyber-related approval risk by ensuring submission environments are secure, controlled, and defensible.
Preparing for What Comes Next
Once approval is granted, regulatory expectations do not stop. Secure submission practices lay the foundation for compliant GMP Manufacturing, ongoing oversight, and future inspections.
Cyber security must continue to support regulated operations beyond approval.
Protect Submission Integrity. Support Regulatory Confidence.
If you’re preparing or managing regulatory submissions and need assurance that your systems and data can withstand regulatory scrutiny, speak to CyberGXP. We’ll help you protect approval timelines and regulatory outcomes.