Post-Market Compliance Management
We assist with post-market incident reporting, including Field Safety Corrective Actions (FSCAs), mandatory problem reporting, and recalls. We monitor regulatory changes, manage reporting obligations, and implement updates, allowing you to focus on growing your business while maintaining full compliance.
Import Solutions
Let us handle the complexities of international trade regulations in the Philippines, Indonesia, and Thailand. As the license holder, we ensure efficient customs clearance and timely delivery, backed by our extensive knowledge of global trade requirements.
Authorized Representative Services
As your dedicated authorized representative, we serve as your trusted liaison with regulatory authorities. Our proactive approach and deep regulatory expertise ensure your interests are protected throughout the process. As an independent license holder, we provide flexibility to work with different distributors, ensuring seamless transitions and full control over your licenses.
Medical Device & IVD Registration
Our seasoned in-house team streamlines complex regulatory requirements, offering a one-stop solution for document preparation, submission, follow-up, and approval. This significantly reduces approval timelines while ensuring full compliance and minimizing risks.
