Regulatory, Quality & Clinical expertise
for MedTech, IVD and Biopharma

Biomedical development support for spin-offs, start-ups, entrepreneurs and research centers—linking scientific development with regulated evidence generation.

• Product concept → regulated plan (requirements, evidence roadmap)
• Clinical/performance evidence planning aligned with intended purpose
• Cross-functional documentation alignment (R&D ↔ QA/RA ↔ Clinical)

Regulatory matters and quality assurance for pharmaceutical, medical device and IVD companies—focused on practical execution and audit readiness.

• IVD registration strategy and technical documentation leadership
• QMS and standards readiness: ISO 13485/9001, ISO 15189, 21 CFR 820
• Clinical/regulatory medical writing: protocols/CTPs, IMPDs, CSRs, narratives

Authorised EU representative (EC REP) for medical devices and IVD, supporting compliant communication and defined responsibilities under EU regulations.

The scope and obligations of an authorised representative are defined by EU rules; we work strictly within that framework.

Organization of clinical research with a comprehensive portfolio of services that can be customized to each project—covering start-up, oversight and coordination.

• Study start-up, logistics and trial management delivery
• Experience across broad therapeutic areas (oncology, neurology, cardiology, respiratory, psychiatry, etc.)
• IVD/MD performance and evaluation study support (selected examples available on request)