Audit Readiness

Preparing for Regulatory Audits with Amtera

Amtera specializes in preparing organizations for regulatory audits and ensuring ongoing compliance with FDA and SwissMedic requirements — by providing qualified specialists and managed workforce solutions. Our comprehensive audit readiness services enable your organization to approach audits with confidence: through in-depth assessments, early identification of compliance risks, and the implementation of corrective measures.

We support your internal teams by providing skilled professionals or by fully managing audit-relevant functions on your behalf. In addition, we offer tailored training programs to strengthen regulatory awareness and facilitate effective communication with auditors. With Amtera by your side, you can proactively close compliance gaps, minimize risks, and reliably demonstrate adherence to regulatory standards.

Audit Readiness

Amtera understands the importance of being audit-ready at all times. Our audit readiness services are delivered through dedicated experts and managed workforce solutions — aligned with your regulatory goals and operational needs. Whether you need targeted support or a fully outsourced approach, we help ensure successful outcomes in FDA and SwissMedic audits.

Key Services

Pre-Audit Preparation

We conduct structured pre-audit assessments to evaluate your audit readiness in line with FDA and SwissMedic expectations. Our experts analyze your documentation, procedures, and workflows to identify potential weaknesses and opportunities for improvement — allowing you to resolve issues before they are flagged in a formal inspection.

Regulatory Compliance Reviews

Amtera’s specialists perform in-depth compliance reviews of your operations, ensuring alignment with relevant FDA and SwissMedic standards. We assess systems, documentation, and processes to validate compliance and highlight areas that may require additional focus.

Audit Planning and Strategy

We support your organization in developing clear, actionable audit strategies. This includes defining roles and responsibilities, setting timelines, and ensuring that resources are effectively allocated — either by your internal team or with the help of Amtera’s managed resources.

Mock Audits and Team Training

To prepare your team for real-world audit situations, we conduct realistic mock audits and training sessions. Our professionals simulate audit conditions, offer targeted feedback, and help refine documentation, processes, and team communication — all tailored to FDA and SwissMedic expectations.

Our Approach

Amtera takes a proactive, partnership-based approach to audit readiness. We work closely with your organization to understand your unique challenges and compliance goals. Depending on your needs, we provide either skilled individual professionals or fully managed teams who take on audit-related responsibilities on your behalf. Our solutions are always tailored to support your regulatory success.

Partner with Amtera to strengthen your audit readiness — with expert support in the form of professionals and managed workforce solutions. Be prepared, be compliant, and be confident.