[vc_section bklyn_overlay=”true” background_position=”center center” section_separator_bottom=”true” section_separator_bottom_zindex=”true” section_separator_svg_bottom=”curve” section_separator_bottom_flip=”true” section_separator_bottom_hide_on_tablet=”” section_separator_bottom_hide_on_mobile=”” el_name=”First Section” css=”.vc_custom_1564106412051{margin-top: 30px !important;margin-right: 30px !important;margin-bottom: 0px !important;margin-left: 30px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;background-image: url(https://new.weareinfinite.mx/wp-content/uploads/2019/07/INFINITE-start-up.jpg?id=4423) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” section_separator_bottom_color_1=”#2c2c2c” bklyn_overlay_color=”rgba(255, 255, 255, 0.8)”][vc_row full_width=”stretch_row_content_no_spaces” css=”.vc_custom_1560893674300{padding-top: 0px !important;}”][vc_column width=”1/3″ css=”.vc_custom_1560389182663{padding-top: 30px !important;padding-right: 30px !important;padding-bottom: 30px !important;padding-left: 30px !important;}” offset=”vc_col-lg-4 vc_col-md-4 vc_col-sm-4 vc_col-xs-12 vc_hidden-xs”][ut_accordion easing=”linear” transition=”300″ count=”no” label_font_size=”15″ css=”.vc_custom_1564681675196{padding-top: 5px !important;padding-right: 15px !important;padding-bottom: 5px !important;padding-left: 15px !important;background-color: rgba(255, 255, 255, 0.86) !important;*background-color: rgba(255,255, 255, 0.86) !important;}” class=”menu-accordion” label_color=”#0a0a0a” text_color=”#81d742″][ut_accordion_item label=”Regulatory Affairs”]
Submission of information for ethics committees
[/ut_accordion_item][ut_accordion_item label=”Clinical Operations”]
[/ut_accordion_item][ut_accordion_item label=”Research Products Storage/Depot”]
Integral management of research products
[/ut_accordion_item][ut_accordion_item label=”Health records before COFEPRIS”]
Requirements of the Mexican regulations
[/ut_accordion_item][ut_accordion_item label=”Consulting Services”]
[/ut_accordion_item][ut_accordion_item label=”Complementary Services”]
[/ut_accordion_item][ut_accordion_item label=”Pharmacovigilance / Technovigilance”]
[/ut_accordion_item][ut_accordion_item open=”true” label=”Business Solutions”]
Preparation of documents for research
Research protocols for medical devices
Research protocols in cosmetics
Import of products of research
Compliance with labelling rules
[/ut_accordion_item][ut_accordion_item label=”Training”]
[/ut_accordion_item][/ut_accordion][/vc_column][vc_column width=”1/2″ offset=”vc_col-lg-offset-0 vc_col-lg-6 vc_col-md-8 vc_col-sm-8 vc_col-xs-12″ css=”.vc_custom_1560893666027{padding-right: 30px !important;padding-left: 30px !important;}”][ultimate_spacer height=”150″ height_on_tabs=”150″ height_on_tabs_portrait=”0″ height_on_mob_landscape=”0″ height_on_mob=”0″][ultimate_heading main_heading=”Start-Up” heading_tag=”h1″ main_heading_color=”#373c48″ main_heading_style=”font-weight:bold;” main_heading_font_size=”desktop:43px;tablet:43px;tablet_portrait:40px;mobile_landscape:40px;mobile:35px;” main_heading_margin=”margin-top:20px;margin-bottom:20px;”][/ultimate_heading][vc_column_text]
In INFINITE we support you to the supervision and administration of all start-up processes that cover all the regulatory procedures that must be carried out prior to the start of a clinical research protocol. Our flexibility as an organization allows us to help you from the initial translations or the adequacy of the research documents to the submission of the information to the regulatory authority.
[/vc_column_text][ut_btn button_effect=”winona” button_size=”bklyn-btn-small” button_custom_border=”yes” button_border_width=”2″ font_family=”inherit” font_weight=”” button_text=”Empezar” button_text_color=”#474b54″ button_background=”transparent” button_border_color=”#004d72″ spacing=”padding-top:15px;padding-right:40px;padding-bottom:15px;padding-left:40px” button_link=”url:%23start-up-services|||” effect=”fadeIn”][/vc_column][/vc_row][vc_row full_width=”stretch_row_content_no_spaces” hide_on_desktop=”true” hide_on_tablet=”true” css=”.vc_custom_1554832684299{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;background-color: #ffffff !important;}”][vc_column offset=”vc_col-lg-offset-0 vc_col-lg-12 vc_col-md-12 vc_col-sm-12 vc_col-xs-12″ css=”.vc_custom_1554832549540{margin-top: 0px !important;margin-bottom: 0px !important;padding-right: 30px !important;padding-left: 30px !important;background-color: #ffffff !important;}”][ut_accordion easing=”linear” transition=”300″ count=”no” label_font_size=”15″ css=”.vc_custom_1564681675196{padding-top: 5px !important;padding-right: 15px !important;padding-bottom: 5px !important;padding-left: 15px !important;background-color: rgba(255, 255, 255, 0.86) !important;*background-color: rgba(255,255, 255, 0.86) !important;}” class=”menu-accordion” label_color=”#0a0a0a” text_color=”#81d742″][ut_accordion_item label=”Regulatory Affairs”]
Submission of information for ethics committees
[/ut_accordion_item][ut_accordion_item label=”Clinical Operations”]
[/ut_accordion_item][ut_accordion_item label=”Research Products Storage/Depot”]
Integral management of research products
[/ut_accordion_item][ut_accordion_item label=”Health records before COFEPRIS”]
Requirements of the Mexican regulations
[/ut_accordion_item][ut_accordion_item label=”Consulting Services”]
[/ut_accordion_item][ut_accordion_item label=”Complementary Services”]
[/ut_accordion_item][ut_accordion_item label=”Pharmacovigilance / Technovigilance”]
[/ut_accordion_item][ut_accordion_item open=”true” label=”Business Solutions”]
Preparation of documents for research
Research protocols for medical devices
Research protocols in cosmetics
Import of products of research
Compliance with labelling rules
[/ut_accordion_item][ut_accordion_item label=”Training”]
[/ut_accordion_item][/ut_accordion][ultimate_spacer height=”” height_on_mob=”70″][/vc_column][/vc_row][/vc_section][vc_section background_attachment=”fixed” section_separator_top=”true” section_separator_top_zindex=”true” section_separator_svg_top=”curve” section_separator_top_flip=”true” section_separator_top_hide_on_tablet=”” section_separator_top_hide_on_mobile=”” el_name=”3 Split Sections for Desktop Variant” section_separator_top_color_1=”#2c2c2c” css=”.vc_custom_1555023184552{padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_row section_separator_bottom=”true” section_separator_svg_bottom=”curve” section_separator_bottom_flip=”true” section_separator_bottom_hide_on_tablet=”” section_separator_bottom_hide_on_mobile=”” section_separator_bottom_color_1=”#005439″ css=”.vc_custom_1564680044012{background-color: #005439 !important;}” el_id=”start-up-services”][vc_column][ultimate_heading main_heading=”Start-up Services” heading_tag=”h3″ main_heading_color=”#ffffff” main_heading_font_size=”desktop:50px;tablet:50px;tablet_portrait:40px;mobile_landscape:22px;mobile:22px;” main_heading_style=”font-weight:bold;”][/ultimate_heading][/vc_column][/vc_row][vc_row full_height=”yes” equal_height=”yes” content_placement=”middle” bklyn_overlay=”true” section_separator_top=”true” section_separator_top_zindex=”true” section_separator_svg_top=”curve” section_separator_top_flip=”true” section_separator_top_hide_on_tablet=”” section_separator_top_hide_on_mobile=”” section_separator_top_color_1=”#005439″ css=”.vc_custom_1564107704587{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;background-image: url(https://new.weareinfinite.mx/wp-content/uploads/2019/07/INFINITE-servicios-start-up-.jpg?id=4421) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” bklyn_overlay_color=”linear-gradient(to top, rgb(255, 255, 255) 0%, rgba(255, 255, 255, 0.62) 100%)”][vc_column offset=”vc_col-lg-12 vc_col-md-12 vc_col-sm-12 vc_col-xs-12″ el_class=”content-section-description” effect=”fadeIn”][ultimate_spacer height=”” height_on_tabs_portrait=”30″ height_on_mob_landscape=”30″ height_on_mob=”30″][vc_column_text]
Our start-up services cover all the regulatory processes that must be carried out prior to the start of a protocol, these can be added in a modular way according to the needs of the client, the services we offer are:
[/vc_column_text][vc_row_inner equal_height=”yes”][vc_column_inner width=”1/4″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697093215{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Identification and evaluation of researchers” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/4″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697093215{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Identification and evaluation of research sites” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/4″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697093215{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Submission to ethics and research committees” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/4″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697093215{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Health authorization of the clinical study” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/4″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697093215{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Import permits” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/4″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697093215{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Adequacy of research documents” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/4″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697093215{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Foreign trade (import and export of inputs)” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/4″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697093215{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Contract administration with central and local sites and laboratories” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][/vc_section][vc_section background_attachment=”fixed” section_separator_top=”true” section_separator_top_zindex=”true” section_separator_svg_top=”curve” section_separator_top_flip=”true” section_separator_top_hide_on_tablet=”” section_separator_top_hide_on_mobile=”” el_name=”3 Split Sections for Desktop Variant” section_separator_top_color_1=”#ffffff” css=”.vc_custom_1564680090178{padding-top: 0px !important;padding-bottom: 0px !important;}” el_id=”preparation-documents-research”][vc_row section_separator_bottom=”true” section_separator_svg_bottom=”curve” section_separator_bottom_flip=”true” section_separator_bottom_hide_on_tablet=”” section_separator_bottom_hide_on_mobile=”” section_separator_bottom_color_1=”#004d72″ css=”.vc_custom_1564107654336{background-color: #004d72 !important;}”][vc_column][ultimate_heading main_heading=”Research documents” heading_tag=”h3″ main_heading_color=”#ffffff” main_heading_font_size=”desktop:50px;tablet:50px;tablet_portrait:40px;mobile_landscape:22px;mobile:22px;” main_heading_style=”font-weight:bold;”][/ultimate_heading][/vc_column][/vc_row][vc_row full_height=”yes” equal_height=”yes” content_placement=”middle” bklyn_overlay=”true” section_separator_top=”true” section_separator_top_zindex=”true” section_separator_svg_top=”curve” section_separator_top_flip=”true” section_separator_top_hide_on_tablet=”” section_separator_top_hide_on_mobile=”” section_separator_top_color_1=”#004d72″ css=”.vc_custom_1564107667881{margin-top: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;background-image: url(https://new.weareinfinite.mx/wp-content/uploads/2019/07/INFINITE-servicios-start-up-.jpg?id=4421) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” bklyn_overlay_color=”linear-gradient(to top, rgb(255, 255, 255) 0%, rgba(255, 255, 255, 0.62) 100%)”][vc_column offset=”vc_col-lg-12 vc_col-md-12 vc_col-sm-12 vc_col-xs-12″ el_class=”content-section-description” effect=”fadeIn”][ultimate_spacer height=”” height_on_tabs_portrait=”30″ height_on_mob_landscape=”30″ height_on_mob=”30″][vc_column_text]
For the beginning of any operation related to clinical research it is necessary to support it with the correct documentation, which is why INFINITE has a team of specialists that support you for the development, validation or legalization of documents for research. Some of our services include:
[/vc_column_text][vc_row_inner equal_height=”yes”][vc_column_inner width=”1/3″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697319334{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Development and review of research protocols” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/3″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697319334{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Preparation, review and adaptation of FCI (Informed Consent Format)” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/3″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697319334{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Tropicalization of study documents” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/3″ offset=”vc_col-lg-offset-2 vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697319334{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Simple and / or certified translations” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][vc_column_inner width=”1/3″ offset=”vc_col-xs-6″][just_icon icon=”Defaults-check” icon_size=”21″ icon_color=”#5c9bcd” css_just_icon=”.vc_custom_1564697319334{margin-top: 15px !important;margin-bottom: 15px !important;}”][ultimate_heading main_heading=”Development of CRF and eCRF (Case Report Form)” heading_tag=”p” main_heading_color=”#2c2c2c” main_heading_font_size=”desktop:17px;”][/ultimate_heading][/vc_column_inner][/vc_row_inner][ultimate_spacer height=”100″ height_on_tabs=”100″ height_on_tabs_portrait=”50″ height_on_mob_landscape=”30″ height_on_mob=”30″][/vc_column][/vc_row][/vc_section][vc_section background_attachment=”fixed” section_separator_top=”true” section_separator_top_zindex=”true” section_separator_svg_top=”curve” section_separator_top_flip=”true” section_separator_top_hide_on_tablet=”” section_separator_top_hide_on_mobile=”” el_name=”3 Split Sections for Desktop Variant” section_separator_top_color_1=”#ffffff” css=”.vc_custom_1561005148306{padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_row section_separator_bottom=”true” section_separator_svg_bottom=”curve” section_separator_bottom_flip=”true” section_separator_bottom_hide_on_tablet=”” section_separator_bottom_hide_on_mobile=”” section_separator_bottom_color_1=”#2c2c2c” css=”.vc_custom_1564684578261{background-color: #2c2c2c !important;}” el_id=”compliance-labelling-rules”][vc_column][ultimate_heading main_heading=”Compliance with Labeling Standards” heading_tag=”h3″ main_heading_color=”#ffffff” main_heading_font_size=”desktop:50px;tablet:50px;tablet_portrait:40px;mobile_landscape:22px;mobile:22px;” main_heading_style=”font-weight:bold;”][/ultimate_heading][/vc_column][/vc_row][vc_row full_height=”yes” equal_height=”yes” content_placement=”middle” bklyn_overlay=”true” section_separator_top=”true” section_separator_top_zindex=”true” section_separator_svg_top=”curve” section_separator_top_flip=”true” section_separator_top_hide_on_tablet=”” section_separator_top_hide_on_mobile=”” section_separator_top_color_1=”#2c2c2c” css=”.vc_custom_1564108295606{margin-top: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;background-image: url(https://new.weareinfinite.mx/wp-content/uploads/2019/07/INFINITE-servicios-start-up-.jpg?id=4421) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” bklyn_overlay_color=”linear-gradient(to top, rgb(255, 255, 255) 0%, rgba(255, 255, 255, 0.62) 100%)”][vc_column offset=”vc_col-lg-12 vc_col-md-12 vc_col-sm-12 vc_col-xs-12″ el_class=”content-section-description” effect=”fadeIn”][ultimate_spacer height=”” height_on_tabs_portrait=”30″ height_on_mob_landscape=”30″ height_on_mob=”30″][vc_column_text]
The information or texts included that contain the labels and instructions of the medicines, herbal remedies and medical devices, are considered health and commercial information which identifies each product, in order to accurately establish its correct identification in the market, for sale and supply, as well as to guide and warn the consumer or patient about the proper and safe use of these health supplies.
These texts must be authorized and delivered by the Ministry of Health either by obtaining a sanitary registration of the medication, the alphanumeric code of herbal remedy or modifications to the registration conditions. INFINITE, as an expert company in the registration of new medicines, offers you its orientation services for compliance with the Official Mexican Standard for the labeling of medicines and herbal remedies (NOM-072-SSA1-2012) so that the product has all the requirements established by the authority and can operate its marketing activities without inconvenience.
[/vc_column_text][/vc_column][/vc_row][/vc_section]