FDA Certification

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services that protects the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biologics, medical devices, cosmetics, food additives, plant pests/diseases, radiological materials and pesticides. The FDA requires a wide array of information on product applications including the chemistry, manufacturing and controls information.

Role of IAS as US-FDA Agent

IAS have proper team who are well acquainted with how to file for US-FDA Licensing and registration procedures. We, IAS has been helping companies to get US-FDA registration as follows:

(1) Drug Registration in US-FDA: Any drug article which is manufactured, processed, packed, or held within the U.S. must be registered with the US-FDA.

(2) Medical Device Registration in US FDA: The company having medical device manufacturing units must register each of their units with the US-FDA. It also includes marketing, importing, labeling, and other related functions too. The companies should seek establishment registration for all of their FDA regulated

IAS is an FDA consulting firm that specializes in FDA submission services. Through years of experience, IAS has consulted many clients on the successful filing of their products with the US-FDA. Due to our expertise and understanding of the rules & regulations, we have been able to register our client’s product successfully.

As a consultant, we guide you through the entire process of filing your IND/IDE to successful FDA registration.

We assist pharmaceutical, biotech and medical device firms with the US Food and Drug Administration’s registration process. We provide expert advice and assistance on all phases of the US FDA registration procedure, in conjunction with our clientele. We conducted significant research on various aspects of the US FDA registration process and devised services to meet the needs of our clients.

We offer the following Services:

1. US-FDA Registration for Food & Food supplements (Nutraceuticals)
2. US-FDA registration of drugs and medicines
3. US-FDA Registration for medical devices & Cosmetics
4. US-FDA registration for In Vitro Diagnostic Device, IVD.
5. US-FDA Registration of Active Pharmaceutical Ingredients (API).
6. US-FDA Registration of Medical and Surgical Instruments and Implants.
7. US-FDA Registration of cosmetics

We take care of each and every aspect – right from the development of a comprehensive strategy to the successful filing of your application.

IAS takes up complete responsibility for your US-FDA registration on your behalf. We take care of each and every aspect – right from the development of a comprehensive strategy to the successful filing of your application. IAS is an FDA consulting firm that specializes in US-FDA registration and we guide you through the entire process of filing your product with the US-FDA successfully.

We have a dedicated team of professionals who are well-versed in this process, and they work as per the guidelines laid down by the US-FDA for registering medical devices before their marketing begins.

The registration number is required to be declared on all labeling including that put out by internet sites. So, you should be aware of all the details related to this before proceeding.

When it comes to US-FDA registration services, IAS is a name that can be trusted upon. Our dedicated team of professionals will help you at each step of the process and guide you through the entire filing process.

Information required for US FDA registration

The Manufacturer will have to prepare a detailed dossier in order to meet the application requirements. The dossier contains four parts:

1) A cover letter with the name, location and title of the person responsible for filing the application;

2) A product labeling section; 3) A description of manufacturing procedures (manufacturing process, facilities used for manufacturing and controls); and 4) Chemistry, Manufacturing and Controls sections.

The FDA recommend that the applicant identify a person to serve as the primary contact between the Agency and business. The name should be representative official and someone who has authority to do the following on behalf of the applicant. IAS plays the role of US-FDA agent:

• Respond to all inquiries from FDA about the application, including inspections.
• Accept or reject agency inspection findings.
• Provide information required for good review management.
• Accept or reject all written regulatory review comments.

One of the most important pieces amongst the application is a thorough description of manufacturing procedures in order to meet FDA guidelines and demonstrate that the manufacturer is in compliance with current good manufacturing practices (cGMP). In addition, appropriate data from stability studies must be supplied when registering drugs. Stability testing helps

The information required for US-FDA registration of medical devices is extensive and the exact details depend on the type of device, its intended use, where you plan to market it etc.

For cosmetics, you will need to follow certain guidelines. However, our experts can guide you on this as well.

When it comes to the US-FDA registration procedure for medical devices, some of the information required includes details about the manufacturer like their name, address etc., details about how your device works and its intended use, etc.

The type of information that you will need to provide also depends on the type of medical device it is. Hence, we offer a wide range of services for this.

IAS is FDA consulting firm and US-FDA Agent and we have been in the business for many years. We understand how important your time is and thus take care of everything related to US-FDA registration at every stage so that you don’t have to deal with the hassles.

Use of US-FDA registration number

The first step in marketing your medical device is to obtain the US-FDA registration number for it. This will be utilized on all labeling, including that provided by internet retailers, so you should be aware of all of the specifics involved with US-FDA registration for medical devices.

Our staff of specialists has expertise in the field and will assist you in beginning on the correct foot when it comes to FDA registration for medical devices. They’ll give total assistance at each stage, ensuring that you don’t run into any snags.

For Free estimation:

To represent as US-FDA Agent or consulting on US-FDA Registration Email: enquiry@iascertification.com.