Regulatory and Compliance.

Ensure your conformity and optimize your processes in accordance with ISO 13485 and other international standards.

Ensure that all changes to your products and processes comply with regulatory requirements.

Ensure the success of your products through smooth and effective interaction with health authorities.

Ensure that your clinical trials comply with regulatory requirements.

Identify and minimize risks with solutions for the pharmaceutical and medical technology industries.

Ensure that your products and processes comply with regulatory requirements.

Secure access to global markets with customized support.

Creation of clear and compliant technical documentation for the pharmaceutical and medical technology industry.

Our IVDR Consulting Services provide you with comprehensive support in complying with IVDR requirements and obtaining market authorization for your products.

Ensure safe and efficient medical devices by implementing the MDR.

Ensure the quality of your non-clinical studies.

We work with you to develop regulatory compliant labels and instructions for use - adapted to MDR, IVDR and target markets.

Fully comply with your UDI and EUDAMED obligations - for MDR and IVDR-compliant medical devices and in-vitro diagnostics.

Master regulatory challenges in cell and gene therapies with a partner that combines experience, structure and depth.

Implement reliable e-records and signatures for maximum data integrity in the pharmaceutical and biotechnology environment.

Take advantage of our expertise for smooth approval and complete documentation of your medical devices.

Navigate safely through Premarket Notification, PMA and De Novo - we will guide you step by step.

Simulate realistic audits and close compliance gaps at an early stage.

Bring your products to market without delay.

Secure your data processes and ensure compliance with international standards.

Ensuring compliance and audit preparation through professional advice and process optimization.