We are your expert strategic IVD and Device development partner streamlining the success of your envisioned product bringing your aspirations to life and promising a better health tomorrow.
Whether it’s an Over-the-Counter (OTC) or Point of Care (POC) in Vitro Diagnostic Device, we provide comprehensive solutions tailored to your product development and commercialization needs. Our expert team will guide you through the entire process, from initial concept to market launch, ensuring that each step is strategically planned and executed with precision.
Developing a medical device is a complex and multifaceted undertaking. We recognize the intricacies and challenges involved in navigating the regulatory landscape. Our expertise and experience allow us to guide you through every phase of the process, ensuring a smooth and efficient path to market.
Acenth is a full-service CRO providing Clinical Trial Management services for the Global IVD and Medical device Industry, while maintaining highest quality, ensuring strict adherence to your trial timeline and budget through collaborative approach.
From protocol design to project management, data analysis to Regulatory consulting and study submission to meeting with FDA, we provide solution from Inception to commercialization. We ensure your unique needs are met with our flexible approach and optimal support in predefined timelines.
Quality, commitment and trustworthiness are the core principles of Acenth.
As medical technologies rapidly evolve, the clinical environment has become more reliant on advanced devices—from robotic surgical tools and implantable monitors
The U.S. Food and Drug Administration (FDA) plays a foundational role in overseeing clinical research involving drugs, biologics, and medical devices.
Medical product labeling serves as a critical conduit between manufacturers, regulators, and healthcare providers. For clinicians and researchers, the label is
Full-service medical device CRO and a one-stop shop for clinical and regulatory services.
