We provide our clients with the best FDA regulatory consultants in demonstrating the science, safety, and efficacy of their technologies.

We streamline the effectiveness and success of clinical trials, advising across every stage of the process – from site qualification to post commercialization.

We evaluate existing and novel technologies’ current and future reimbursement coding, coverage and payment options, and work to achieve your company’s goals of impacting trends and changes in healthcare policy.

Our expertise lies in connecting you with key opinion leaders in various therapy fields, facilitating research collaborations. This strategic partnership aims to garner acceptance and recognition within the US local medical community, enhancing your product’s credibility and market presence.

We offer specialized US Agent services, essential for non-US medical device companies distributing in the USA. As mandated by the FDA, manufacturers, contract manufacturers, and specifications developers based outside the USA must appoint a US agent. Our role is to facilitate effective communication between these companies and the FDA, ensuring compliance and smooth operation within the US market

Our quality assurance team combines their in-depth knowledge to cover the strict FDA and global quality assurance requirements to ensure product consistency and safety.

With the continued advancement in technology and medical devices, Our cybersecurity experts for medical devices provide full integrated services to secure and protect your medical device or software as a medical device solution by leading the discussions and delivering thorough risk assessments, strategy, and advisory services.