Mikhail Yefimenko

After receiving his BSc 16 years ago, Mr. Yefimenko began a successful career in regulatory affairs, which has culminated in the senior advisory role he plays today. As an accomplished regulatory expert with a broad grasp of clinical, non-clinical and manufacturing requirements, he has worked for major pharmaceutical companies, CROs, medical device manufacturers and combination product companies.

Mr. Yefimenko’s areas of experience include oncology, cardiovascular, dermatology, dental, endocrine, metabolic and gastrointestinal disease areas. He has an extensive working knowledge of FDA 510(k), IDE, PMA and international medical device registrations including EU, Australia, Canada, Asian and other Rest of World markets.

In addition to his extensive regulatory knowledge, Mr. Yefimenko has a long history of personal interactions with regulatory bodies such as the FDA, EMA, rapporteurs and notified bodies, including a broad experience of preparing for and passing regulatory audit. He brings to Limmedx a unique combination of strategic regulatory insight, strong operational skills and a detail-oriented, hands-on approach to modern regulatory affairs and quality system implementation.

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