Remediation Activities

Amtera is your partner for targeted remediation measures that close regulatory gaps, strengthen data integrity, and systematically reduce compliance risks. Our specialised experts support you in analysing, planning, and implementing corrective actions – practical, efficient, and fully aligned with regulatory expectations.

Our Services

Document Review & Correction

We analyse existing quality documents for inconsistencies, formal deficiencies, and deviations from internal or regulatory standards (e.g. EU-GMP, FDA, ISO). Our subject matter experts provide targeted recommendations and support updates – ensuring complete, audit-ready documentation.

SOP Review & Optimisation

We evaluate your existing SOPs for clarity, relevance, and compliance. Together with your team, we develop clearly structured, practical, and compliant procedures – providing a solid foundation for daily operations and inspections.

Remediation Planning & Execution

define prioritised actions, timelines, and responsibilities, ensuring all corrections are implemented efficiently, on time, and fully documented for regulatory authorities and auditors.

Training & Change Management

Amtera supports internal implementation with hands-on training and targeted change management. We help your teams adopt new procedures and ensure sustainable integration of improved practices.

Our Approach

Amtera follows a structured, collaborative, and resource-driven approach. We provide experienced professionals who strengthen your internal teams – whether for urgent corrective actions, external inspections, or internal compliance transformations.