ARETE-ZOE

Arete-Zoe, LLC is a consultancy providing solutions for complex challenges in global pharmaceuticals, medical devices, clinical research, healthcare informatics, and public health. Its services combine specialized expertise with a systems approach to developing and implementing practical solutions.

For medical device manufacturers, Arete-Zoe supports access to the European market by preparing technical documentation for submissions under EU Medical Devices Regulation 2017/745. The company also assists with communications and follow-up involving notified bodies and national competent authorities. Its research services help pharmaceutical and device organizations meet compliance obligations and inform decisions. These services include scientific literature screening, evidence summaries, clinical evaluation and post-market follow-up support, safety-report research, and study-related documentation.

Arete-Zoe also designs and develops tailored training programs, from needs analysis and curriculum planning to materials and evaluation strategies, helping organizations build internal expertise. Its operational risk management work addresses organizational vulnerabilities across policies, procedures, staffing, technology, and training, with support for planning, analysis, exercises, and resilience. The consultancy serves clients across pharmaceutical, medical technology, biotechnology, and related life science sectors.