[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_row _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_cta _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb background_color=\u00bb#0B0B7A\u00bb hover_enabled=\u00bb0″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb sticky_enabled=\u00bb0″ min_height=\u00bb164px\u00bb]<\/p>\n

The USA dominates the global pharma market both in consumption and in development, securing the spot as the largest pharma market in the world<\/strong>. While barriers to commercialization for local US pharma companies are low,<\/strong> the barriers to entry for foreign pharma companies are quite high. One notoriously difficult barrier to entry for foreign pharma companies seeking to enter the US market is achieving FDA approval.<\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n

[\/et_pb_cta][et_pb_cta title=\u00bbRegulatory Body – FDA\u00bb _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb header_text_color=\u00bb#000000″ body_text_color=\u00bb#000000″ background_color=\u00bb#bbccee\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n

The regulatory body in the USA responsible for the registrations is called the Food and Drug administration.<\/a><\/p>\n

[\/et_pb_cta][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb min_height=\u00bb906px\u00bb custom_margin=\u00bb-72px|||||\u00bb custom_padding=\u00bb||20px|||\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_row column_structure=\u00bb1_2,1_2″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n

Pharma Prescription Drugs<\/h2>\n
Having several different categories of drugs, Pharma regulatory in the USA might seem a bit overwhelming at first. The pharma\/prescription drug registration process can be complex and easy<\/strong> at the same time depending on the experience and network<\/strong> with the FDA and other local experts.<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
Consumer Healthcare Drugs\/OTC<\/h2>\n
In the US, Consumer Healthcare and OTC drugs<\/strong> are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional.<\/strong>
There are two regulatory paths for the legal marketing of OTC drug products<\/strong> in the US depending on whether there already exists an OTC monograph in the USA for the OTC drug in question. OTC drugs containing ingredients that comply with an existing monograph are considered to be \u201cgenerally recognized as safe and effective\u201d<\/strong> and do not require specific FDA approval before marketing.
With our long-term experience and network with the FDA, we can offer a relatively fast registration process for Consumer Healthcare & OTC drugs in America.<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_2,1_2″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
Medical Devices<\/h2>\n
In the USA, Medical Devices are controlled based on a classification system. There are three classes of Medical Devices (I, II, and III)<\/strong> based on the degree of risk they present, and as the class increases, the regulatory controls also increase. Class I devices are subject to the least regulatory control and class III, the most.<\/p>\n
In addition to having different classes, different regulatory pathways also exist for bringing your medical device to the market. There are more than four different types of premarket submissions,<\/strong> and the pathway needed depends on several variables including the type of medical device and its class. A class I exemption also exists for specific devices which do not require premarket submissions.<\/p>\n
\u00a0<\/strong><\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
Food Supplements\/Nutraceuticals<\/h2>\n
FDA regulates dietary supplements under a different set of regulations than those covering \u201cconventional\u201d foods and drug products.<\/strong><\/p>\n
In general, a Food Supplements\/Nutraceuticals registration process in the USA is relatively fast and easy. The FDA has a list of ingredients that are allowed in the products, along with their minimum and maximum quantities. Depending on these ingredients, the product might be exempt from registration.<\/p>\n
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[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_2,1_2″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
Cosmetics and Derma<\/h2>\n
In the USA, The law does not require cosmetic products and ingredients, other than colour additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce. By definition, cosmetics in the US are \u201carticles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body\u2026for cleansing, beautifying, promoting attractiveness, or altering the appearance\u201d<\/p>\n
By law, cosmetic products in the US do not require FDA premarket approval,<\/strong> but the FDA can pursue enforcement action against products on the market that are not in compliance with the law.<\/p>\n
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[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_image src=\u00bbhttps:\/\/www.chameleon-pharma.com\/wp-content\/uploads\/USA-scaled.jpg\u00bb alt=\u00bbView of the Empire State Building in the middle of New York\u00bb title_text=\u00bbNew York City\u00bb _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_image][et_pb_text _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb text_font_size=\u00bb10px\u00bb min_height=\u00bb41px\u00bb custom_margin=\u00bb-37px|||||\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
Photo by John Fornander<\/a> on Unsplash<\/a><\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ admin_label=\u00bbTabs\u00bb _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb-83px|||||\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_row _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.15″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
Frequently Asked Questions from clients – Regulatory Affairs<\/h2>\n
[\/et_pb_text][et_pb_tabs _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_tab title=\u00bbFAQ – Prescription Products\u00bb _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
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Will my existing BE studies be accepted in the USA?<\/li>\n
What are the important things to take understand with regards to
trademarks by the FDA?<\/li>\n
Can my home company act as a MAH in the USA?<\/li>\n
What is the difference in climate zone for stability studies in the US vs. Europe and Asia?<\/li>\n
Is the fast track registration process possible for my products in the USA and what to be aware of?<\/li>\n
What are the pharma\/prescription drug registration costs and time in the USA?<\/li>\n<\/ul>\n
[\/et_pb_tab][et_pb_tab title=\u00bbFAQ – OTC Products\u00bb _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
\n
How many trademarks should be suggested to the FDA\u2019s DMEPA and why?<\/li>\n
How can my own company be MAH in the USA for my products?<\/li>\n
What are the Consumer Healthcare Drugs\/OTC registration costs and time in the USA?\u00a0<\/li>\n
How to register Herbal and Phyto OTC drugs in the USA via fast track process and why to prepare the market entry strategy before?<\/li>\n
What do I need to know about climate zone for stability studies in the USA?<\/li>\n
Is a fast track registration process available in the USA and what to make sure of?<\/li>\n<\/ul>\n
[\/et_pb_tab][et_pb_tab title=\u00bbFAQ – Medical Devices\u00bb _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
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What is the difference between Medical Device registration and definition in US vs. Europe, Asia and throughout Latin America?<\/li>\n
Is my product considered a Medical Device by the laws of the FDA?<\/li>\n
What are the important differences in trademark registration in the USA with regards to the FDA for Medical Devices?<\/li>\n
Are local clinical trials necessary in the USA?<\/li>\n
Can my company act as a MAH in the USA?<\/li>\n
Climate zone for stability studies in the USA<\/li>\n
Is a fast track registration process available in the USA and what to be aware of?<\/li>\n
How difficult is the registration of Medical Devices in the USA?<\/li>\n
What are the Medical Devices registration costs and time in the USA?\u00a0<\/li>\n
To which class of Medical Devices does my product belong?<\/li>\n<\/ul>\n
[\/et_pb_tab][et_pb_tab title=\u00bbFAQ – FS and Neutraceuticals\u00bb _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
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How to register claims on the pack for Food Supplements in the USA with the FDA?<\/li>\n
Why trademark registration in the USA can be a very difficult task with the FDA?<\/li>\n
Can my company act as a MAH in the USA for Food Supplements?<\/li>\n
What Climate zone for stability studies do I need for Food Supplements in the USA?<\/li>\n
How difficult is the registration of Food Supplements\/Nutraceuticals in the USA?<\/li>\n
What are the Food Supplements\/Nutraceuticals registration costs and time in the USA?<\/li>\n<\/ul>\n
[\/et_pb_tab][et_pb_tab title=\u00bbFAQ – Cosmetics and Derma\u00bb _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
\n
How to register claims in the USA for Cosmetics with the FDA?<\/li>\n
Why is the trademark registration for Cosmetics and Derma products a big topic in the USA?<\/li>\n
Can my company act as a MAH in the USA or do I need a local partner for registration?<\/li>\n
What are the important topics about climate zone for stability studies in the USA?<\/li>\n
How difficult is the registration of Cosmetics in the USA?<\/li>\n
What are Cosmetics registration costs and time in the USA?<\/li>\n<\/ul>\n
[\/et_pb_tab][\/et_pb_tabs][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ custom_padding_last_edited=\u00bbon|desktop\u00bb admin_label=\u00bbAbout Chameleon\u00bb _builder_version=\u00bb4.15.1″ min_height=\u00bb407.4px\u00bb custom_margin=\u00bb-46px||||false|false\u00bb custom_padding=\u00bb12px|0px|30px|0px|false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb0px||0px||false|false\u00bb global_module=\u00bb11867″ saved_tabs=\u00bball\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_row _builder_version=\u00bb4.15″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.15″ custom_padding=\u00bb|||\u00bb global_colors_info=\u00bb{}\u00bb custom_padding__hover=\u00bb|||\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_cta title=\u00bbAbout Chameleon Pharma Consulting\u00bb button_url=\u00bbhttps:\/\/www.chameleon-pharma.com\/about\/who-we-are\/\u00bb button_text=\u00bbMore about us\u00bb admin_label=\u00bbCTA\u00bb _builder_version=\u00bb4.15″ body_font=\u00bb||||||||\u00bb background_color=\u00bb#0B0B7A\u00bb custom_button=\u00bbon\u00bb button_text_size=\u00bb16px\u00bb button_text_color=\u00bb#ffffff\u00bb button_bg_color=\u00bb#30B7E8″ button_border_width=\u00bb10px\u00bb button_border_color=\u00bbrgba(210,159,104,0)\u00bb button_border_radius=\u00bb100px\u00bb button_use_icon=\u00bboff\u00bb max_width=\u00bb900px\u00bb max_width_last_edited=\u00bboff|desktop\u00bb module_alignment=\u00bbcenter\u00bb min_height=\u00bb107.4px\u00bb custom_margin=\u00bb69px|||||\u00bb custom_padding=\u00bb60px|40px|60px|40px|true|true\u00bb animation_style=\u00bbzoom\u00bb animation_intensity_zoom=\u00bb2%\u00bb header_font_size_tablet=\u00bb30px\u00bb header_font_size_phone=\u00bb24px\u00bb header_font_size_last_edited=\u00bbon|phone\u00bb box_shadow_style=\u00bbpreset3″ box_shadow_vertical=\u00bb100px\u00bb box_shadow_blur=\u00bb100px\u00bb box_shadow_spread=\u00bb-60px\u00bb button_text_color_hover=\u00bb#3550a0″ button_bg_color_hover=\u00bb#ffffff\u00bb global_colors_info=\u00bb{}\u00bb button_text_size__hover_enabled=\u00bboff\u00bb button_one_text_size__hover_enabled=\u00bboff\u00bb button_two_text_size__hover_enabled=\u00bboff\u00bb button_text_color__hover_enabled=\u00bbon\u00bb button_text_color__hover=\u00bb#3550a0″ button_one_text_color__hover_enabled=\u00bboff\u00bb button_two_text_color__hover_enabled=\u00bboff\u00bb button_border_width__hover_enabled=\u00bboff\u00bb button_one_border_width__hover_enabled=\u00bboff\u00bb button_two_border_width__hover_enabled=\u00bboff\u00bb button_border_color__hover_enabled=\u00bboff\u00bb button_one_border_color__hover_enabled=\u00bboff\u00bb button_two_border_color__hover_enabled=\u00bboff\u00bb button_border_radius__hover_enabled=\u00bboff\u00bb button_one_border_radius__hover_enabled=\u00bboff\u00bb button_two_border_radius__hover_enabled=\u00bboff\u00bb button_letter_spacing__hover_enabled=\u00bboff\u00bb button_one_letter_spacing__hover_enabled=\u00bboff\u00bb button_two_letter_spacing__hover_enabled=\u00bboff\u00bb button_bg_color__hover_enabled=\u00bbon\u00bb button_bg_color__hover=\u00bb#ffffff\u00bb button_one_bg_color__hover_enabled=\u00bboff\u00bb button_two_bg_color__hover_enabled=\u00bboff\u00bb theme_builder_area=\u00bbpost_content\u00bb]We at Chameleon Pharma Consulting are the experts with more than 20 years of experience in areas such as Consumer Healthcare, Pharma Rx, Cosmetics, Food Supplements, FMCG, Wholesale, Retail, Production.[\/et_pb_cta][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ admin_label=\u00bbServices\u00bb _builder_version=\u00bb4.15″ use_background_color_gradient=\u00bbon\u00bb background_color_gradient_start=\u00bbrgba(240,242,246,0.5)\u00bb 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Our services<\/h2>\n
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About Anthony<\/h1>\n
Business CoacH<\/h3>\n
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam. Lorem ipsum dolor sit amet, cons[\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"
USA – Regulatory Affairs The USA dominates the global pharma market both in consumption and in development, securing the spot as the largest pharma market in the world. While barriers to commercialization for local US pharma companies are low, the barriers to entry for foreign pharma companies are quite high. One notoriously difficult barrier to […]<\/p>\n","protected":false},"author":7,"featured_media":0,"parent":8765,"menu_order":18,"comment_status":"open","ping_status":"open","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"\r\n
The USA dominates the global pharma market both in consumption and in development, securing the spot as the largest pharma market in the world. While barriers to commercialization for local US pharma companies is low, the barriers to entry for foreign pharma companies are quite high. One notoriously difficult barrier to entry for foreign pharma companies seeking to enter the US market is achieving FDA approval.<\/p>\r\n\r\n\r\n\r\n
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Click on the segment to read more<\/strong><\/h4>\r\n\r\n\r\n\r\n
Pharma\/Pre<\/u><\/strong>scription Drugs<\/u><\/strong><\/a><\/p>\r\n\r\n\r\n\r\n
Consumer Healthcare Drugs\/OTC Drugs<\/a><\/u><\/strong><\/p>\r\n\r\n\r\n\r\n
Medical Devices<\/a><\/u><\/strong><\/p>\r\n\r\n\r\n\r\n
Food Supplements\/Nutraceuticals<\/a><\/u><\/strong><\/p>\r\n\r\n\r\n\r\n
Cosmetics & Derma<\/a><\/u><\/strong><\/p>\r\n\r\n\r\n\r\n
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Our Services & experience<\/strong>
<\/p>\r\n\r\n\r\n\r\n
We have more than 20 years of experience in the USA, we would gladly guide you through the maze of the regulatory affairs with our local network. We will also make sure that the whole registration process of your product in the USA is very clear to you.<\/p>\r\n\r\n\r\n\r\n
We do not have a standard approach to regulatory affairs, but rather tailor our services to the expectations and needs of our clients.<\/p>\r\n\r\n\r\n\r\n
Some examples:\u00a0 <\/strong>
1. A very detailed yet easy to understand flow chart with the pharma\/prescription drug registration process in the USA<\/em>
2. A full overview of Medical Devices registration timeline and costs in the USA<\/em><\/p>\r\n\r\n\r\n\r\n
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$\"\"$
1. The USA Registration Process - Tips & Tricks<\/figcaption><\/figure>\r\n<\/div>\r\n\r\n\r\n\r\n
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2. The USA Registration Process - Time & Cost<\/figcaption><\/figure>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n\r\n
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U.S. Food and Drug Administration<\/strong><\/strong><\/h3>\r\n\r\n\r\n\r\n
$\"\"$ <\/figure><\/div>\r\n\r\n\r\n\r\n
The regulatory body in the USA responsible for the registrations is called the Food and Drug administration. Click here to go to the official website of the<\/a> FDA<\/p>\r\n\r\n\r\n\r\n
Contact us<\/a> to get answers to all your individual product and situation questions!<\/p>\r\n\r\n\r\n\r\n
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Pharma\/Prescription Drugs<\/strong><\/h3>\r\n\r\n\r\n\r\n
<\/p>\r\n<\/div><\/div>\r\n\r\n\r\n\r\n
Overview<\/strong><\/p>\r\n\r\n\r\n\r\n
Having several different categories of drugs, Pharma regulatory in the USA might seem a bit overwhelming at first. The pharma\/prescription drug registration process can be complex and easy at the same time depending on the experience and network with the FDA and other local experts.<\/p>\r\n\r\n\r\n\r\n
Below we have listed the questions that our clients usually have with regards to Pharma drug registrations in the USA:<\/p>\r\n\r\n\r\n\r\n
Will my existing BE studies be accepted in the USA?<\/li>
What are the important things to take understand with regards to
trademarks by the FDA?<\/li>
Can my home company act as a MAH in the USA?<\/li>
What is the difference in climate zone for stability studies in the US vs. Europe and Asia?<\/li>
Is the fast track registration process possible for my products in the USA and what to be aware of?<\/li>
What are the pharma\/prescription drug registration costs and time in the USA?\u00a0<\/li><\/ul>\r\n\r\n\r\n\r\nContact us<\/a> about your questions on your Pharma and medicine registration in the USA!<\/p>\r\n\r\n\r\n\r\n
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Consumer Healthcare Drugs\/OTC<\/strong><\/h3>\r\n\r\n\r\n\r\n
<\/p>\r\n<\/div><\/div>\r\n\r\n\r\n\r\n
Overview<\/strong><\/p>\r\n\r\n\r\n\r\n
In the US, Consumer Healthcare and OTC drugs are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional.<\/p>\r\n\r\n\r\n\r\n
There are two regulatory paths for the legal marketing of OTC drug products in the US depending on whether there already exists an OTC monograph in the USA for the OTC drug in question. OTC drugs containing ingredients that comply with an existing monograph are considered to be \u201cgenerally recognized as safe and effective\u201d and do not require specific FDA approval before marketing.<\/p>\r\n\r\n\r\n\r\n
With our long-term experience and network with the FDA, we can offer a relatively fast registration process for Consumer Healthcare & OTC drugs in America.<\/p>\r\n\r\n\r\n\r\n
Please see below the questions that our clients usually have on the Consumer Healthcare & OTC drugs registration process in the US:<\/p>\r\n\r\n\r\n\r\n
How many trademarks should be suggested to the FDA\u2019s DMEPA and why?<\/li>
How can my own company be MAH in the USA for my products?<\/li>
What are the Consumer Healthcare Drugs\/OTC registration costs and time in the USA?\u00a0<\/li>
How to register Herbal and Phyto OTC drugs in the USA via fast track process and why to prepare the market entry strategy before?<\/li>
What do I need to know about climate zone for stability studies in the USA?<\/li>
Is a fast track registration process available in the USA and what to make sure of?<\/li><\/ul>\r\n\r\n\r\n\r\nContact us<\/a> to learn more about Consumer Healthcare Drug\/OTC registration in the USA!<\/p>\r\n\r\n\r\n\r\n
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Medical Devices<\/strong><\/h3>\r\n\r\n\r\n\r\n
<\/p>\r\n<\/div><\/div>\r\n\r\n\r\n\r\n
Overview<\/strong><\/p>\r\n\r\n\r\n\r\n
In the USA, Medical Devices are controlled based on a classification system. There are three classes of Medical Devices (I, II, and III) based on the degree of risk they present, and as the class increases, the regulatory controls also increase. Class I devices are subject to the least regulatory control and class III, the most. <\/strong><\/p>\r\n\r\n\r\n\r\n
In addition to having different classes, different regulatory pathways also exist for bringing your medical device to the market. There are more than four different types of premarket submissions, and the pathway needed depends on several variables including the type of medical device and its class. A class I exemption also exists for specific devices which do not require premarket submissions.<\/p>\r\n\r\n\r\n\r\n
The questions that our clients usually ask about Medical Device Registration in the USA with the FDA:<\/p>\r\n\r\n\r\n\r\n
What is the difference between Medical Device registration and definition in US vs. Europe, Asia and throughout Latin America?<\/li>
Is my product considered a Medical Device by the laws of the FDA?<\/li>
What are the important differences in trademark registration in the USA with regards to the FDA for Medical Devices?<\/li>
Are local clinical trials necessary in the USA?<\/li>
Can my company act as a MAH in the USA?<\/li>
Climate zone for stability studies in the USA<\/li>
Is a fast track registration process available in the USA and what to be aware of?<\/li>
How difficult is the registration of Medical Devices in the USA?<\/li>
What are the Medical Devices registration costs and time in the USA?\u00a0<\/li>
To which class of Medical Devices does my product belong?<\/li><\/ul>\r\n\r\n\r\n\r\nContact us<\/a> to learn more about Medical Devices registration in the USA!<\/p>\r\n\r\n\r\n\r\n
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Food Supplements\/Nutraceuticals<\/strong><\/h3>\r\n\r\n\r\n\r\n
<\/p>\r\n<\/div><\/div>\r\n\r\n\r\n\r\n
Overview<\/strong><\/p>\r\n\r\n\r\n\r\n
FDA regulates dietary supplements under a different set of regulations than those covering \"conventional\" foods and drug products.<\/strong><\/p>\r\n\r\n\r\n\r\n
In general, a Food Supplements\/Nutraceuticals registration process in the USA is relatively fast and easy. The FDA has a list of ingredients that are allowed in the products, along with their minimum and maximum quantities. Depending on these ingredients, the product might be exempt from registration.<\/p>\r\n\r\n\r\n\r\n
The questions that our clients usually ask about the Food Supplement registration with the FDA in the USA:<\/p>\r\n\r\n\r\n\r\n
How to register claims on the pack for Food Supplements in the USA with the FDA?<\/li>
Why trademark registration in the USA can be a very difficult task with the FDA?<\/li>
Can my company act as a MAH in the USA for Food Supplements?<\/li>
What Climate zone for stability studies do I need for Food Supplements in the USA?<\/li>
How difficult is the registration of Food Supplements\/Nutraceuticals in the USA?<\/li>
What are the Food Supplements\/Nutraceuticals registration costs and time in the USA?\u00a0<\/li><\/ul>\r\n\r\n\r\n\r\nContact us<\/a> to learn more about Food Supplements\/Nutraceuticals registration in the USA!<\/p>\r\n\r\n\r\n\r\n
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Cosmetics & Derma<\/strong><\/h3>\r\n\r\n\r\n\r\n
<\/p>\r\n<\/div><\/div>\r\n\r\n\r\n\r\n
Overview<\/strong><\/p>\r\n\r\n\r\n\r\n
In the USA, The law does not require cosmetic products and ingredients, other than colour additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce. <\/strong>By definition, cosmetics in the US are \"articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance\"<\/p>\r\n\r\n\r\n\r\n
By law, cosmetic products in the US do not require FDA premarket approval, but the FDA can pursue enforcement action against products on the market that are not in compliance with the law. The questions that our clients usually ask us about cosmetic and derma registrations in the USA with the FDA are the following:<\/p>\r\n\r\n\r\n\r\n
How to register claims in the USA for Cosmetics with the FDA?<\/li>
Why is the trademark registration for Cosmetics and Derma products a big topic in the USA?<\/li>
Can my company act as a MAH in the USA or do I need a local partner for registration?<\/li>
What are the important topics about climate zone for stability studies in the USA?<\/li>
How difficult is the registration of Cosmetics in the USA?<\/li>
What are Cosmetics registration costs and time in the USA?<\/li><\/ul>\r\n\r\n\r\n\r\nContact us<\/a> to learn more about Cosmetics registration in the USA!<\/p>\r\n","_et_gb_content_width":"","footnotes":"","_wp_rev_ctl_limit":""},"class_list":["post-8866","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.chameleon-pharma.com\/es\/wp-json\/wp\/v2\/pages\/8866","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.chameleon-pharma.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.chameleon-pharma.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.chameleon-pharma.com\/es\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/www.chameleon-pharma.com\/es\/wp-json\/wp\/v2\/comments?post=8866"}],"version-history":[{"count":7,"href":"https:\/\/www.chameleon-pharma.com\/es\/wp-json\/wp\/v2\/pages\/8866\/revisions"}],"predecessor-version":[{"id":14676,"href":"https:\/\/www.chameleon-pharma.com\/es\/wp-json\/wp\/v2\/pages\/8866\/revisions\/14676"}],"up":[{"embeddable":true,"href":"https:\/\/www.chameleon-pharma.com\/es\/wp-json\/wp\/v2\/pages\/8765"}],"wp:attachment":[{"href":"https:\/\/www.chameleon-pharma.com\/es\/wp-json\/wp\/v2\/media?parent=8866"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}