Myusoffice Alachua

Have you ever wonder how cool it would be to have a virtual presence of your establishment inside the United States? Have you ever thought of your customers who actually can pick up the phone and reach out to someone in the United States for basic information without making an international call? Then we are here to help you! Imagine someone who can meet your customer on your behalf and represent your company while you are thousands of miles away and you still can achieve your business goal without you moving from your desk. Imagine someone representing your establishment, products in a local tradeshow, seminar, and meetings just like your loyal employee at home. Imagine someone who can guide you through all local logistics of every aspect of your successful business. If you are really into lean business practice and would like to benefit out of the smarter way of working, you are in the right place. We are just a call away. See what we can do for you: We are proud to offer following customized services to our clients: � Your Virtual Office (Mailing Address & Phone) � Your Deligate in the US (Representation) � DemonstrateExhibit your product in an Exhibition) � Participate in a meetingseminar on your behalf � Participate in a tradeshow on your behalf � CustomerSupplier visit on your behalf � Negotiate with CustomerSupplier on your behalf � Sourcing a ProductService for your company � Other business assignment

Sourcing & Procurement Are you looking for a product or a manufacturer or a service provider? Are you looking for a strategic supplier? We can help. We can source your productservice with great confidence and confidentiality. Our client is our first priority before anything else. What do we do? We have years of experience sourcing products for Aerospace, Medical Device and many other Industrial and manufacturing portfolio. No matter how complicated productservice it is, we will find it for you with a reasonable price and good quality. How does it work? We are very flexible to work with. We can either accept a percentage of a sourced product or flat fees as consultation or we can source and sell directly to you. Just tell us what you need, we will be glad to help. Mange Supplybase: Do you have huge supply base that is hard to manage and frequently run into regulatory and financial risk? Are you looking towards consolidating your supply base with a strategic partner? How do you manage your supply base risk? Do you have an adequate system in place to track and monitor your supplier performance? Cost Engineering: Are you looking for competitive pricing? Have you ever thought of how much profit your supplier is making from the products you are buying? Are you paying the fair market value? What happens when your supplier is unable to supply you part?

Sourcing & Procurement Are you looking for a product or a manufacturer or a service provider? Are you looking for a strategic supplier? We can help. We can source your productservice with great confidence and confidentiality. Our client is our first priority before anything else. What do we do? We have years of experience sourcing products for Aerospace, Medical Device and many other Industrial and manufacturing portfolio. No matter how complicated productservice it is, we will find it for you with a reasonable price and good quality. How does it work? We are very flexible to work with. We can either accept a percentage of a sourced product or flat fees as consultation or we can source and sell directly to you. Just tell us what you need, we will be glad to help. Mange Supplybase: Do you have huge supply base that is hard to manage and frequently run into regulatory and financial risk? Are you looking towards consolidating your supply base with a strategic partner? How do you manage your supply base risk? Do you have an adequate system in place to track and monitor your supplier performance? Cost Engineering: Are you looking for competitive pricing? Have you ever thought of how much profit your supplier is making from the products you are buying? Are you paying the fair market value? What happens when your supplier is unable to supply you part? If your business is really growing and you would like to minimize your supply base risk, we can help. Tell us what you need: Premium Services: � Sourcing & Procurement � Supplier Risk Management � Cost Engineering � Strategic Growth � Cost Reduction

Domestic and foreign establishments that manufacture, repack, distribute or re-label certain drug, food, medical device, and cosmetics may require registration with FDA. The requirement for each type of registration may vary. For example, The owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration. Products that may require FDA registration are: � Animal and Veterinary Drugs � Cosmetics (Voluntary) � Drugs � Food � Medical Devices � Radiation-Emitting Products � Products � Vaccines, Blood, Biologics Responsibilities of a U.S. Agent: Our service includes: � Registration Processing � US FDA Registration Number Notification � Product Classifications � Annual FDA Registration Renewal Processing

Why do you need an FDA U.S. Agent? U.S. Food & Drug Administration (FDA) requires you to appoint a United States Agent (FDA U.S. Agent) if: � You are a Foreign Establishment (Located outside of United States) and � You are engaged in: � Manufacturing or � Preparation or � Propagation or � Processing of a medical device that is � Imported to the United States Responsibilities of a U.S. Agent: The responsibilities of U.S. Agent are limited and include: � Assisting FDA in communication with your establishment � Responding to questions concerning the devices that are imported or offered for import into the United States. � Assisting FDA in scheduling inspections of your establishment and � If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered or equivalent to providing the same information or documents to the foreign establishment.