01
Changes and updates
Regulatory changes, variations, and renewals.
Specialized service
Post-Registration and Regulatory Audits
We protect portfolio validity and assess the strength of registrations, supporting evidence, and regulatory teams.
How we approach it
A directed pathway, with clear scope and control at every stage.
02
Obligation monitoring
Commitments, reports, and renewals within the required deadlines.
03
Document review
Integrity, currency, consistency, and traceability.
04
Regulatory audit
Independent assessment of registrations, evidence, processes, and capabilities.
05
Regulatory continuity
Expert support to preserve validity and availability.
Regulatory audit
Two perspectives to strengthen regulatory control.
The scope is tailored to the portfolio, organization, and required depth and may include, without limitation, the following approaches.
Registration audits
We review the supporting evidence for an approved registration and compare it with the applicable regulations. The report covers, among other matters, compliance level, information validity, registration confidence, and recommended corrective and preventive actions.
Technical and regulatory affairs department audits
We assess the regulatory team’s organization, processes, controls, and capabilities. Drawing on our methodology, experience, lessons learned, and current regulations, we identify gaps and improvement opportunities and deliver an implementation plan.
What to expect
An objective view of compliance, risks, and the actions required to strengthen regulatory management.
Scope, deliverables, and responsibilities are defined for your product, country, and objective. You retain visibility of progress and receive expert judgment at key decision points.
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