FDA Registration Services.
U.S. FDA
FDA Registration Services: Comprehensive Services for US FDA Registration
If you need FDA Registration Services, we offer comprehensive support, from FDA Documentation Services to obtaining licenses. As experts in FDA Regulatory Consulting, we guide you through the process of registering with the US FDA and applying online, ensuring compliance with all standards. We assist you every step of the way, from document preparation to dealing with the FDA.
FDA Registration Services.
U.S. FDA
FDA Registration Services: Comprehensive Services for US FDA Registration
If you need FDA Registration Services, we offer comprehensive support, from FDA Documentation Services to obtaining licenses. As experts in FDA Regulatory Consulting, we guide you through the process of registering with the US FDA and applying online, ensuring compliance with all standards. We assist you every step of the way, from document preparation to dealing with the FDA.
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Open for service Monday – Friday (09.00 – 18.00)
Our FDA Registration Services
Comprehensive FDA Licensing and Registration Services
Whether you need FDA Registration Services or assistance with FDA documentation, we provide comprehensive solutions. As specialists in FDA Regulatory Consulting, we help with all aspects of FDA registration and online applications, ensuring compliance with the required standards and providing guidance from document preparation to final FDA submissions.
Legal Requirements for FDA Registration
- Federal Food, Drug, and Cosmetic Act (FDCA) : The primary law regulating food, drugs, cosmetics, and medical devices in the US.
- Drug Approval Process : Rules and procedures for drug approval, including submitting a New Drug Application (NDA).
- Food Safety Modernization Act (FSMA) : A law focused on preventing food contamination and enhancing food safety standards.
- Medical Device Amendments (MDA) : Updates related to the regulation of medical devices.
- Cosmetic Regulation : Laws and guidelines for controlling cosmetics and beauty products.
- Dietary Supplement Health and Education Act (DSHEA) : Regulates dietary supplements in the US.
- Public Health Security and Bioterrorism Preparedness and Response Act : Laws related to food safety and preventing bioterrorism.
- FDA Food Safety Modernization Act (FSMA) : A law that emphasizes preventing food safety issues rather than correcting them after they occur.
FDA Licensing Fees
ค่าธรรมเนียมสำหรับการขออนุญาตยาภายใต้ New Drug Application (NDA)
| รายการ | ค่าธรรมเนียม | หมายเหตุ |
|---|---|---|
| Standard NDA | ประมาณ $2,900,000 USD | - |
| Abbreviated NDA (ANDA) | ประมาณ $1,450,000 USD | - |
ค่าธรรมเนียมสำหรับการขออนุญาตอาหารและเครื่องสำอาง
| รายการ | ค่าธรรมเนียม | หมายเหตุ |
|---|---|---|
| Food Facility Registration | ไม่มีค่าธรรมเนียม | (แต่ต้องมีการลงทะเบียนทุก 2 ปี) |
| Cosmetic Registration | ไม่มีค่าธรรมเนียม | (แต่ต้องลงทะเบียนข้อมูลในระบบ) |
ค่าธรรมเนียมสำหรับการขออนุญาตอุปกรณ์ทางการแพทย์
| รายการ | ค่าธรรมเนียม | หมายเหตุ |
|---|---|---|
| Premarket Notification (510(k)) | ประมาณ $14,500 USD | - |
| Premarket Approval (PMA) | ประมาณ $366,000 USD | - |
ค่าธรรมเนียมสำหรับการขออนุญาตผลิตภัณฑ์เสริมอาหาร
| รายการ | ค่าธรรมเนียม | หมายเหตุ |
|---|---|---|
| Supplemental New Dietary Ingredient (NDI) Notification | ไม่มีค่าธรรมเนียม | (แต่ต้องยื่นเอกสารและข้อมูลการทดสอบ) |
Our FDA Registration Services
We ensure smooth operations and compliance with FDA regulations. We offer expert consultation and FDA registration services, including professional document management and submission for US FDA registration.
Our FDA Registration Services Cover :
- FDA Regulatory Affairs
- FDA Filing Services
- FDA Approval Consulting
- FDA Product Registration
- FDA Compliance Assistance
- FDA Label Review Services
- FDA Import/Export Consulting
- FDA Audit Preparation
These services help you navigate the licensing process efficiently and effectively.
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We specialize in FDA registration for various products, including :
Medical Devices
Dietary Supplements
Toys
Cosmetics
Food
Drugs
We also offer FDA registration services for small and medium-sized enterprises (SMEs) and new businesses. Contact us today to inquire about US FDA registration fees and get more information on FDA application processes. We provide professional and experienced services to help your business enter the US market confidently and legally.
Specialized FDA Consulting Services
We are also experts in CFR21 Part 11, the FDA’s requirements for electronic record-keeping in the pharmaceutical and food industries. For Leiters 503B manufacturers, we offer specialized consulting to ensure compliance with set standards. Additionally, we provide CE FDA services for those looking to expand into the European Union alongside the US FDA.
We have expertise in FDA regulations such as FDA 175, FDA 176, and FDA 177.1550, which pertain to food-contact materials. If you’re interested in FDA ES (Emergency Services) or FDA Innovent, we offer valuable information and guidance. We also provide consulting on FDA MOPH (Ministry of Public Health) for those who need to understand the relationship between the US FDA and other countries’ health ministries.
For those who want to know about FDA PL (Private Label) or what FDA registration entails, we have complete and easy-to-understand information. We are also experts in food-related FDA matters and can provide the latest information on new drug approvals, such as Mirati FDA approval. For niche brands like Monat FDA or Rompe Pecho FDA, we offer specialized knowledge to assist with FDA processes efficiently.
We also offer consulting services related to TH FDA and Thai FDA regulations for those looking to understand the differences between Thai and US FDA. Finally, we provide guidance on using Web FDA to ensure smooth online interactions with the FDA. Contact us today for comprehensive services tailored to your FDA registration and compliance needs.
IntBizTH We are happy to provide consulting services, FDA registration and information preparation. to allow the permission process is fast don't waste time
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