Regulatory Gap Assessment & Remediation
Identifying Compliance Risks Early and Implementing Targeted Corrective Measures
Incomplete technical documentation, evolving regulatory requirements, or discrepancies between existing processes and current regulations can significantly affect regulatory submissions and products already on the market.
Avary Consulting supports companies in systematically evaluating their regulatory compliance status.
Our gap assessments are based on applicable requirements, including the EU MDR, EU IVDR, FDA regulations, European pharmaceutical legislation, and relevant quality management standards.
We identify regulatory gaps, assess their potential impact, and support the development of prioritized remediation plans.
Our services include:
Structured regulatory compliance assessments
Evaluation of technical and quality-related documentation
Identification of regulatory deficiencies and compliance risks
Prioritization of required corrective actions
Support for the implementation of remediation activities
Follow-up and evaluation of action effectiveness
Our Recommendation: Regulatory gap assessments should not be postponed until immediately before a regulatory submission or inspection. Early assessment provides greater transparency regarding compliance risks, resource requirements, and necessary corrective actions.