ENEM Consulting

ENEM Consulting is a private life sciences consulting firm focused on regulatory, quality, and clinical support for medical device, in vitro diagnostic, and combination product companies. The firm positions itself as a liaison between the FDA and medical device companies and offers worldwide regulatory strategy, submission support, clinical and quality systems consulting, and due diligence services. Its services span product development requirements, pre-clinical and clinical planning, FDA and international submissions, and support for interactions with regulatory agencies and notified bodies. ENEM Consulting appears to operate as a service provider rather than a therapeutic product developer, so it does not have a traditional drug pipeline.