Our core competencies

We stand by you in a more and more complex regulatory environment. Together, we work out a solution perfectly tailored to your requirements.

Biological Safety Evaluation and Toxicological Risk Assessments (ISO 10993-series)

Sterility Assurance

Deviations in Quality & Complaint Handling (NC, CAPA, Complaints)

Medical Device Regulatory Affairs (RA)

Packaging Development

Verification and Validation (V&V)

Product Development (R&D)

Supplier Quality Management (SQM)