Authorized Representative
Your Trusted Partner in Authorized Representation
Authorized Representatives Or Responsible Person Required To Be Appointed Before You Sell In These Markets. OMC And Its Affiliates Can Support You In Most Countries Around The Globe
our mission is to empower businesses by navigating the complex landscape of regulatory compliance. We understand the crucial role of Authorized Representatives and Responsible Persons in facilitating market entry, and we are here to support your journey.
Why Choose OMC Medical for Your Translation Needs?
- Expertise in Medical Device Terminology
- Certified Quality Assurance Processes
- Native-Speaking Translators with Regulatory Knowledge
- Fast Turnaround Times without Compromising Quality
- Competitive Pricing Models
Explore Our Diverse Range of Translation Services
In case of e-IFUs, current versions in the applicable local languages should be readily accessible by the end user on the manufacturer’s website or any preferred public sharing platform.
Expertise in Regulatory Affairs Our team comprises regulatory experts with in-depth knowledge of the requirements and standards necessary for market access in diverse regions.
Global Network With OMC and its affiliates, you gain access to a vast global network. We can support you in most countries around the globe, ensuring your products meet regulatory standards internationally.
Quality Assurance We maintain rigorous quality standards in all our processes and services.
Comprehensive Support From appointing Authorized Representatives to facilitating communication with regulatory authorities, we offer comprehensive support throughout the regulatory compliance process.
Empowering Global Market Access
We are on a mission to simplify the path to global market access. Understanding the significance of Authorized Representatives, we offer comprehensive support to companies aiming to expand their presence in markets around the world.
- We act as your Authorized Representative, handling the necessary regulatory submissions and communications with local authorities.
- Our team provides the support required to appoint a Responsible Person in compliance with market regulations.
- OMC and its affiliates offer support in numerous countries, making us a comprehensive solution for your global market entry needs.
Crafting Excellence, Inspiring Innovation
We conduct a thorough assessment of your products and target markets to determine the regulatory requirements. Based on our assessment, we develop a customized strategy to ensure compliance in each market, providing you with a clear roadmap for market entry. Throughout the process, we maintain open and proactive communication, keeping you informed about regulatory changes, approvals, and market access status.
Ready to Streamline Your Regulatory Compliance?
Join hundreds of companies who trust OMC Medical for their regulatory needs.
