Frequently Asked Questions PDF Print E-mail

General Questions

  1. WHAT IS THE FDA?

  2. WHY REGISTER WITH THE FDA?

  3. HOW DO I SELL MY FOOD PRODUCTS IN THE U.S.?

  4. HOW DO I SELL MY COSMETICS IN THE U.S.?

  5. HOW DO I SELL MY MEDICAL DEVICE PRODUCTS IN THE U.S.?

  6. WHAT DOES THE REGISTRATION PROCESS INVOLVE?

  7. WHAT IS A U.S. AGENT?

  8. WHAT IS AN OFFICIAL CORRESPONDENT?

  9. DO I NEED A U.S. AGENT OR AN OFFICIAL CORRESPONDENT?

  10. WHAT IS AN ESTABLISHMENT?

  11. WHAT IS FDA ESTABLISHMENT REGISTRATION?

  12. HOW LONG IS AN ESTABLISHMENT REGISTRATION VALID FOR?

  13. WHO NEEDS TO REGISTER?

  14. WHY USE FDAREGISTRATION.NET FOR MY REGISTRATION NEEDS?

  15. WHAT DOES THE REGISTRATION PROCESS INVOLVE?

  16. DOES REGISTRATION TAKE A LOT OF TIME AND EFFORT?

  17. HOW LONG DOES IT TAKE TO PROCESS A REGISTRATION?

  18. WHAT FACILITIES ARE EXEMPT FROM REGISTRATION?

  19. WHAT IS AN OWNER/OPERATOR?

  20. WHAT ARE CONSIDERED ESTABLISHMENT ACTIVITIES?

  21. WHEN IS THE DEADLINE FOR REGISTRATION?

  22. WHAT HAPPENS IF MY FACILITY FAILS TO REGISTER?

  23. I SOLD MY FACILITY. MAY I TRANSFER MY REGISTRATION TO THE NEW OWNER?

  24. WHAT DOES IT MEAN TO CANCEL A REGISTRATION?

  25. DOES THE LAW ONLY COVER U.S. BUSINESSES?

  26. WHY SHOULD THE U.S. LAW COVER BUSINESS OUTSIDE OF THE U.S.

  27. WHAT IS PRODUCT LISTING?

  28. WHAT ARE EXAMPLES OF FDA-REGULATED FOODS?

  29. WHAT FOODS ARE NOT COVERED?

  30. CAN I RECEIVE THIS INFORMATION IN MY NATIVE LANGUAGE?

  31. WHAT IF MY COUNTRY DOESN'T USE ZIP CODES (POSTAL CODES)?

  32. HOW CAN I REVIEW INFORMATION THAT I HAVE SUBMITTED?

  33. DO YOU ACCEPT CREDIT CARDS?

  34. WHERE ARE PRICES LISTED ON FDAREGISTRATION.NET?

Answers

  1. WHAT IS THE FDA?
    • The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
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  2. WHY REGISTER WITH THE FDA?
    • The marketing of medical devices, pharmaceuticals, cosmetics, foods, beverages, and dietary supplements in the U.S. presents an excellent business opportunity for any company.
    • Due to strict regulations, companies are required to appoint a U.S. agent and register their facilities and/or products with the Food and Drug Administration (FDA). Severe consequences of non-compliance with FDA standards range from shipment detention at the U.S. customs to significant monetary fines and other legal enforcement measures. Simply put, if you do not comply and obtain a FDA Registration Number from a U.S agent your shipments will not be allowed entry into the USA.
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  3. HOW DO I SELL MY FOOD PRODUCTS IN THE U.S.?
    • Food products are required to obtain a premarketing clearance or approval from the FDA before they can be placed into commercial distribution in the U.S., unless such device/product is considered exempt. Once your food products have been approved by the FDA, FDARegistration.net will be able to register your food facility in order to enter commercial distribution in the Unites States.
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  4. HOW DO I SELL MY COSMETICS IN THE U.S.?
    • Unlike other products, Cosmetics are NOT required to obtain a premarketing clearance or approval from the FDA before they can be placed into commercial distribution in the U.S. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law by not complying with cosmetic ingredient requirements. If your product is deemed safe by FDA standards, FDARegistration.net may then register your cosmetics facility.
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  5. HOW DO I SELL MY MEDICAL DEVICE PRODUCTS IN THE U.S.?
    • Medical Devices are required to obtain a premarketing clearance or approval from the FDA before they can be placed into commercial distribution in the U.S., unless such device is considered exempt. Once your medical device(s) have been approved by the FDA, FDARegistration.net will be able to register your medical device facility and list your device(s) with the FDA in order to enter commercial distribution in the Unites States.
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  6. WHAT DOES THE REGISTRATION PROCESS INVOLVE?
    • Create a free user account with FDARegistraion.net
    • You will need to fill out our account creation form including general business/contact information and provide a unique Username and Password.
    • Once you have created an account, you will receive a confirmation email where you will be asked to confirm your email address by clicking on a confirmation link.
    • Once you have confirmed your free member account, you will be able to overview our full list of services and their corresponding prices.
    • In order to register any facility or product, you must first appoint FDARegistration.net as your Official Correspondent and U.S. Agent (non-U.S. companies only).
    • Once you have decided to appoint FDARegistration.net as your U.S. Agent (non-U.S. companies only) you will be directed to a payment confirmation page where you will be asked to accept our U.S. Agent and Official Correspondent Agreement, enter payment information, and be able to verify pricing information once again.
    • Once you are a member of FDARegistration.net and have appointed us as your U.S. Agent and Official Correspondent, you may then begin registering your facilities and/or listing your products by selecting the "REGISTER" link and review all of our services including their respective pricing information.
    • Select the appropriate service (i.e. Register My Facility, List a Product, Renew My Registration, etc.) and you will be directed to a corresponding registration form. Simply fill out and submit the short registration form, enter payment information, and you will receive an email confirmation confirming your registration.
    • Within 5-7 business days you will receive your registration number and supplementary confirmation information via email.
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  7. WHAT IS A U.S. AGENT?
    • In accordance with US FDA regulations, any foreign establishment engaged in the manufacture of a product or device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment. Each foreign establishment may designate only one U.S. agent and provide the FDA with the name, address, telephone and fax numbers and e-mail address of the U.S. agent.
    • The foreign establishment should also, but is not required to, designate its U.S. agent as its Official Correspondent.
    • The responsibilities of the U.S. agent include:
      • Assisting FDA in communications with the foreign establishment.
      • Responding to questions concerning the foreign establishment's products or devices that are imported or offered for import into the United States.
      • Assisting FDA in scheduling inspections of the foreign 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 to be equivalent to providing the same information or documents to the foreign establishment.
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  1. WHAT IS AN OFFICIAL CORRESPONDENT?
    • An official correspondent is defined as the person designated by the owner or operator of an establishment responsible for the annual registration of the establishment and product or device listing. The official correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments.
    • The official correspondent is responsible for the registration and listing information for each establishment to which he/she is assigned. The official correspondent can:
      • Create new registrations and listings
      • Make changes, updates and cancellations to registrations and listings that have been assigned to them.
      • Add their establishment(s) to listings previously entered for the owner/operator.
      • View registration and listing information for the establishments which have been created by or assigned to them.
      • View the non-exempt listings that must be replaced for the establishments which have been assigned to them.
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  2. DO I NEED A U.S. AGENT OR AN OFFICIAL CORRESPONDENT?
    • By law you are required to appoint an Official Correspondent and a U.S. Agent (for non-U.S. companies). The registration process is very complex and involves direct communication with the FDA for many aspects. An experienced Official Correspondent will be able to save you a great deal of time and bureaucratic hassle by acting as your direct representative to the FDA.
    • For non-U.S. companies, FDARegistration.net will not be able to process new registrations and/or listing without being appointed BOTH your U.S. Agent AND your Official Correspondent.
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  3. WHAT IS AN ESTABLISHMENT?
    • An establishment is any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution
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  4. WHAT IS FDA ESTABLISHMENT REGISTRATION?
    • Establishments involved in the production and distribution of medical devices, foods, beverages, dietary supplements, drugs, and cosmetics intended for marketing or commercial distribution in the United States are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of manufacturing facilities and importers.
    • NOTE:
      • Registration of an establishment is not an approval of the establishment or its products by FDA. This means that a medical device is required to obtain a premarketing clearance or approval from the FDA before it can be placed into commercial distribution in the U.S., unless such device is considered exempt.
    • NOTE:
      • US regulations state that any representation that creates an impression of official approval because of FDA registration or possession of a registration number is misleading and constitutes misbranding. Product labeling and Internet sites cannot reference your establishment registration number or make reference to your establishment being registered or approved by FDA. If your product labeling or Internet sites list your establishment registration number or makes reference to your establishment being registered and approved by the FDA, then these references must be removed.
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  5. HOW LONG IS AN ESTABLISHMENT REGISTRATION VALID FOR?
    • Each establishment registration is valid for one fiscal year (October 1st through September 30th). Firms must complete their annual registration
      establishment requirement between October 1st and December 31st of each year for the registration to be valid.
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  6. WHO NEEDS TO REGISTER?
    • Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.
    • Domestic facilities are required to register whether or not food from the facility enters interstate commerce.
    • Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.
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  7. WHY USE FDAREGISTRATION.NET TO PROVIDE MY REGISTRATION SERVICES?
    • LEGAL CONFIDENCE
      • As the the only New York based online FDA registration company to be under the supervision of a team of experienced attorneys, the FDARegistration.net staff is knowledgeable and experienced in dealing with all of the complex rules, regulations and legislations involved in the FDA Registration process. We efficiently help U.S. and non-U.S. companies overcome any obstacles encountered by the bureaucracy of complex paperwork and formalities while remaining in the confines of all pertaining laws.
      • Avoid any civil or criminal liability by employing the expert services of FDARegistration.net.
    • SECURITY AND SPEED
      • Protect your valuable personal and business information by using FDARegistration.net, the only certified secure FDA Registration service. We securely and safely transmit any information between parties. FDARegistration.net holds client confidentiality in the utmost regard.
      • With the ONLY truly fully automated, easy to use, customer friendly, and secure registration system on the planet, we offer our clients peace of mind and lighting speed when it comes to their registration needs.
    • PRICING
      • FDARegistration.net offers competitive pricing for all FDA registration services. We not only offer a fully automated submission service, the support of a legal advisory team, and the fastest and easiest FDA registration process available, but we are proud to do so at fair and competitive rates.
    • EXPERIENCE
      • Our staff of trained professionals have been working in the FDA regulated industries for over 20 years and have represent 100’s of companies as their U.S. Designated Agent and as their Official Correspondent.
      • There are many pieces of mandatory and optional information that must be provided by each applicant. We are able to properly and efficiently take care of most of these queries without a single question to you.
    • SAVE TIME AND MONEY
      • With the only fully automated and securely SSL encrypted system, FDARegistration.net is able to register you with the FDA faster, safer, and more efficiently than any other agent.
      • FDARegistration.net is experienced and knowledgeable in all aspects of the FDA registration process. Without this knowledge and due to even the slightest error, companies that attempt to register manually through the FDA are often disqualified from receiving an FDA Registration Number and are forced to go through a re-submission process.
      • Other severe consequences of non-compliance with FDA standards range from shipment detention at the U.S. customs to significant monetary fines and other legal enforcement measures. We save you time, money, and stress by doing it properly and securely the very first time.
    • MULTI-LINGUAL
      • FDARegistration.net offers our online FDA registration service in over 20 of the world's most prominent languages. Our multi-lingual online registration service offer international clients piece of mind when it comes to understanding valuable information during the submission process.
    • CUSTOMER SUPPORT
      • Our customer service representatives are available seven days a week from 8am to 6pm Eastern Standard Time. Any and all questions, if not placed within our normal business hours, are addressed and answered within 10 hours.
      • Our online forum is a great place for question and answer sessions with an experienced FDA compliance specialist.
      • Once FDARegistration.net has ensured a valid registration with the FDA, we hold your business valuable and will continue to provide support at any time it is needed As your U.S. agent, FDARegistration.net communicates between the FDA and you for all alerts, notices and communications in order to comply with any rules, regulations, and laws.
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  8. WHAT DOES THE REGISTRATION PROCESS INVOLVE?
    • In order to register a facility or list products/devices with the FDA, a company must first appoint an Official Correspondent and a U.S. Agent (non-U.S. based companies only).
    • Once you have appointed an Official Correspondent and a U.S. Agent (non-U.S. based companies only) you may register a facility.
    • Once you have registered a facility you may then list products.
    • FDARegistration.net can help you quickly and easily complete this process.
    • FDARegistraion.net also maintains detailed records of all registrations/listings so that when the time comes to re-register annually, FDARegistration.net sends email reminders and notifications to our clients to ensure them that we are fully prepared to offer quality FDA registration and compliance services for years to come.
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  9. DOES REGISTRATION TAKE A LOT OF TIME AND EFFORT?
    • No. We have designed a fully automated system that, on average, should take no more than 20 minutes of your time.
    • The FDA’s forms call for over 185 data elements and FDA says the filing could take up to 12 hours (without expert help).
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  10. HOW LONG DOES IT TAKE TO PROCESS A REGISTRATION?
    • Submissions will be processed in the order they are received and will be turned-around within a 24-hour period, if all of the provided information is error free. Submitters should expect to receive their registration number within five to seven days after processing.
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  11. WHAT FACILITIES ARE EXEMPT FROM REGISTRATION?
    • Private residences of individuals, even though food may be manufactured/processed, packed, or held there.
    • Non-bottled water drinking water collection and distribution establishments and structures, such as municipal water systems.
    • Transport vehicles that hold food only in the usual course of their business as carriers.
    • Farms, i.e., facilities in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves, and cooling of produce are considered part of harvesting. The term "farm" also includes facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership, and facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership. A farm-operated roadside stand that sells food directly to consumers as its primary function would be exempt from registration as a retail food establishment.
    • Restaurants, i.e., facilities that prepare and sell food directly to consumers for immediate consumption, including pet shelters, kennels, and veterinary facilities that provide food directly to animals. Facilities that provide food to interstate conveyances, such as commercial aircraft, or central kitchens that do not prepare and serve food directly to consumers are not restaurants for purposes of the rule.
    • Retail food establishments, such as groceries, delis, and roadside stands, that sell food directly to consumers as their primary function, meaning that annual sales directly to consumers are of greater dollar value than annual sales to other buyers. An establishment that manufactures/processes, packs, or holds food and whose primary function is to sell food directly to consumers, including food that the establishment manufactures/processes, from that establishment is a retail food establishment and is not required to register.
    • Nonprofit food establishments, which are charitable entities that meet the terms of § 501(c)(3) of the Internal Revenue Code and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S. Central food banks, soup kitchens, and nonprofit food delivery services are examples of nonprofit food establishments.
    • Fishing vessels that harvest and transport fish. Such vessels may engage in practices such as heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel and remain exempt.
    • Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture, that is, facilities handling only meat, poultry or egg products.
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  12. WHAT IS AN OWNER/OPERATOR?
    • An owner/operator is defined as the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registered establishment.
    • The owner/operator can:
      • Create and update all of the official correspondents’ FURLS accounts, including their own account(s).
      • Assign official correspondents to registrations.
      • Create new registrations and listings.
      • Make changes, updates and cancellations to registrations and listings that they created.
      • View registration and listing information for the establishments that they created.
      • View all non-exempt listings belonging to the owner/operator that must be replaced.
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  13. WHAT ARE CONSIDERED ESTABLISHMENT ACTIVITIES?
    • Contract Manufacturer
      • Manufactures a finished device to another establishment's specifications.
    • Contract Sterilizer
      • Provides a sterilization service for another establishment's devices.
    • Foreign Exporter
      • Exports or offers for export to the United States (U.S.), a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
    • Initial Distributor
      • Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address.
    • Manufacturer
      • Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
    • Repackager
      • Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
    • Relabeler
      • Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
    • Reprocessor of Single Use Devices
      • Performs re-manufacturing operations on a single use device.
    • Specification Developer
      • Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.
    • U. S. Manufacturer of Export Only Devices
      • Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.
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  14. WHEN IS THE DEADLINE FOR REGISTRATION?
    • The owner, operator, or agent in charge of a facility that manufactures/processes, packs or holds food for consumption in the U.S. must register the facility no later than October 1st. Facilities that begin to manufacture/process, pack, or hold food for consumption in the U.S. on or after October 1st, must register before they begin such activities.
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  15. WHAT HAPPENS IF MY FACILITY FAILS TO REGISTER?
    • Failure to register is a prohibited act under the Federal Food, Drug and Cosmetic Act. You may be subject to civil or criminal sanctions. If an unregistered foreign facility attempts to import food into the United States, the food will be held at the port of entry unless FDA or U.S. Customs directs otherwise. In that case, you will be responsible for moving it and any costs associated with the move and subsequent storage.
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  16. I SOLD MY FACILITY. MAY I TRANSFER MY REGISTRATION TO THE NEW OWNER?
    • A change in the owner of a facility requires a new registration. If the facility comes under new ownership the former owner must cancel the old registration within 60 calendar days of the change. The new owner must submit a new registration for the facility and should supply the previous owner's name and registration number if known.
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  17. WHAT DOES IT MEAN TO CANCEL A REGISTRATION?
    • If a registration is canceled, it means the facility is no longer registered. If the facility needs to be re-registered, a completely new registration will need to be created.
    • A facility canceling its registration must do so within 60 calendar days of the reason for cancellation (e.g., facility ceases operations, ceases providing food for consumption in the U.S., or the facility is sold to a new owner).
    • FDA will cancel a registration if the agency independently verifies that the facility is no longer in business or has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration, or if FDA determines that the registration is for a facility that does not exist. If FDA cancels a facility's registration, FDA will mail a notification of the cancellation to the facility at the address provided in the facility's registration.
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  18. DOES THE LAW ONLY COVER U.S. BUSINESSES?
    • No. It covers food companies all over the world, within and outside of the US.
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  19. WHY SHOULD THE U.S. LAW COVER BUSINESS OUTSIDE OF THE U.S.?
    • Because your products are being sold in the U.S. market.
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  20. WHAT IS PRODUCT LISTING?
    • Most device and product establishments required to register with FDA must also identify to FDA the devices and/or products they have in commercial distribution including devices/products produced exclusively for export. This process is known as product listing.
    • For example, when listing Medical Devices, FDA regulations provide a separate classification for each medical device and can be found in Title 21 Code of Federal Regulations Parts 862-892. Each regulation number or device name is associated with one or more product codes. Regulation numbers with more than one product code identifies the product in further detail. For example, "Manual Surgical Instruments for General Use," 21 CFR 878.4800, contains several product codes including GAB (disposable suturing needle), GDX (scalpel), HTD (forceps) and HRQ (hemostat).
    • NOTE:
      • Listing of a device/product is not approval of the establishment or a device/product by the FDA. Unless exempt, premarketing clearance is required before a device/product can be marketed in the U.S
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  21. WHAT ARE EXAMPLES OF FDA-REGULATED FOODS?
    • Food and food additives for man or animals
    • Dietary supplements and dietary ingredients
    • Infant formula
    • Beverages (including alcoholic beverages and bottled water)
    • Fruits and vegetables
    • Fish and seafood
    • Dairy products and shell eggs
    • Raw agricultural commodities for use as food or components of food
    • Canned foods
    • Live food animals
    • Bakery goods, snack food, and candy
    • Additives such as colors, preservatives and flavors.
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  22. WHAT FOODS ARE NOT COVERED?
    • Chicken and beef are usually exempt
    • Packaging materials such as cans, corks, and bottles
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  23. CAN I RECEIVE THIS INFORMATION IN MY NATIVE LANGUAGE?
    • Yes. FDARegistration.net offers all information in over 20 of the world’s most prominent languages.
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  24. WHAT IF MY COUNTRY DOESN'T USE ZIP CODES (POSTAL CODES)?
    • If your area does not use Zip codes (postal codes) or if there is no information available for any other specific text field in a mandatory section, enter the words "Not Available," "N/A," or "None" in that text field unless specified otherwise.
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  25. HOW CAN I REVIEW INFORMATION THAT I HAVE SUBMITTED?
    • When you submit your initial registration a copy of the information you submitted will be sent to you by postal mail or by e-mail if you provided an e-mail address. Keep this information for your records. If you require any additional information at any time, please contact our customer service center.
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  26. DO YOU ACCEPT CREDIT CARDS?
    • We are gladly accept Visa, Mastercard, Discover, American Express and PayPal
      visalogo mclogo discoverlogoamex
    • We also accept Bank-to-Bank Money Wire Transfer, which is considered the safest international payment method
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  27. WHERE ARE PRICES LISTED ON FDAREGISTRATION.NET?
    • In order to review prices, FDARegistration.net requires all new clients to fill out a "New Client Application". Once FDARegistration.net receives and reviews this application, the new client receives a telephone call from a customer service representative for verbal confirmation of their submitted information. FDARegistration.net does this for two reasons:
      1). We hold client security and privacy in the utmost regard and use many essential precautionary means to ensure that these standards are upheld,
      2). Our philosophy at FDARegistration.net is that each and every client deserves personal attention and this process allows us to build a communicable relationship with each and every client.
    • Once verbal confirmation has been made, the client is granted access to our list of service fees.
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