[fullwidth background_color=”” background_image=”” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_repeat=”no-repeat” background_position=”left top” video_url=”” video_aspect_ratio=”16:9″ video_webm=”” video_mp4=”” video_ogv=”” video_preview_image=”” overlay_color=”” overlay_opacity=”0.5″ video_mute=”yes” video_loop=”yes” fade=”no” border_size=”0px” border_color=”” border_style=”” padding_top=”20″ padding_bottom=”20″ padding_left=”” padding_right=”” hundred_percent=”no” equal_height_columns=”no” hide_on_mobile=”no” menu_anchor=”” class=”” id=””][title size=”1″ content_align=”left” style_type=”default” sep_color=”” margin_top=”25px” margin_bottom=”25px” class=”” id=””]Clinical Trials[/title][imageframe lightbox=”no” gallery_id=”” lightbox_image=”” style_type=”none” hover_type=”none” bordercolor=”” bordersize=”0px” borderradius=”0″ stylecolor=”” align=”center” link=”” linktarget=”_self” animation_type=”0″ animation_direction=”down” animation_speed=”0.1″ animation_offset=”” hide_on_mobile=”no” class=”” id=””] [/imageframe][title size=”1″ content_align=”left” style_type=”default” sep_color=”” margin_top=”25px” margin_bottom=”25px” class=”” id=””][/title][fusion_text]Vyal is dedicated to developing innovative medicines that bring value to patients living with serious diseases. From first-in-man administration to commercialization, we are currently pursuing clinical studies involving thousands of patients around the world. Our teams provide global support to achieve regulatory approvals, as well as post-approval and life-cycle management initiatives.

One of the most important steps in this process are clinical trials, where people volunteer to receive an experimental therapy and be observed for its effects.  Our fully integrated Clinical Development operations range from early-stage to full clinical development management of the organization’s clinical trials.  In addition, our Medical Organization, focused on advancing scientific and medical knowledge, manages Phase IV and registry studies.

[/fusion_text][one_full last=”yes” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”” padding=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ animation_offset=”” class=”” id=””][/one_full][one_full last=”yes” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”” padding=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ animation_offset=”” class=”” id=””][/one_full][/fullwidth][fullwidth background_color=”” background_image=”” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_repeat=”no-repeat” background_position=”left top” video_url=”” video_aspect_ratio=”16:9″ video_webm=”” video_mp4=”” video_ogv=”” video_preview_image=”” overlay_color=”” overlay_opacity=”0.5″ video_mute=”yes” video_loop=”yes” fade=”no” border_size=”0px” border_color=”” border_style=”” padding_top=”20″ padding_bottom=”20″ padding_left=”” padding_right=”” hundred_percent=”no” equal_height_columns=”no” hide_on_mobile=”no” menu_anchor=”” class=”” id=””][title size=”1″ content_align=”center” style_type=”default” sep_color=”” margin_top=”25px” margin_bottom=”25px” class=”” id=””]Assessment times for clinical trials[/title][one_sixth last=”no” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”” padding=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ animation_offset=”” class=”” id=””][/one_sixth][two_third last=”no” spacing=”yes” center_content=”yes” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”solid” padding=”” margin_top=”” margin_bottom=”” animation_type=”0″ animation_direction=”down” animation_speed=”0.1″ animation_offset=”” class=”” id=””][fusion_text]

Product groups pursuant to Section 32  Period for the evaluation 
Allergens, vaccines, biotechnology medicinal products 30 days
Biological products (human / animal origin) 60 days
Somatic cell therapeutics; gene transfer medicinal products, GMOs 60 days
Xenogenic cell therapeutics none

[/fusion_text][/two_third][one_sixth last=”yes” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”” padding=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ animation_offset=”” class=”” id=””][/one_sixth][/fullwidth][fullwidth background_color=”” background_image=”” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_repeat=”no-repeat” background_position=”left top” video_url=”” video_aspect_ratio=”16:9″ video_webm=”” video_mp4=”” video_ogv=”” video_preview_image=”” overlay_color=”” overlay_opacity=”0.5″ video_mute=”yes” video_loop=”yes” fade=”no” border_size=”0px” border_color=”” border_style=”” padding_top=”20″ padding_bottom=”20″ padding_left=”” padding_right=”” hundred_percent=”no” equal_height_columns=”no” hide_on_mobile=”no” menu_anchor=”” class=”” id=””][fusion_text]After the conforming the receipt of the documents, different periods apply for the evaluation of different medicinal products by the competent authority pursuant to the GCP regulation. The periods referenced here are not total periods for the processing of the requests but solely periods for the evaluation of the content of the documents by the CA.

If the request is without formal non-conformities, a confirmation of receipt will be sent to the applicant, and the day after the receipt at the PEI shall be the first day of the evaluation of the content by the PEI. The evaluation period is 30 days for allergens, vaccines and biotechnology medicinal products, 60 days for biological products (of human/animal origin), and 90 days for gene transfer medicinal products and genetically manipulated organisms (GMOs). No periods apply for xenogenic cell therapeutics.

After the evaluations of the contents of the request, the applicant will either be notified of the grounds for non-acceptance, or, if no such grounds have been found, the approval certifcate.

If grounds for non-acceptance were communicated, the applicant shall be granted a period of 90 days to answer these grounds by amending the request. After submission of the amendment, the PEI shall have a period of 15 or 30 days, depending on the medicinal product, to evaluate the amendment.[/fusion_text][/fullwidth][fullwidth background_color=”” background_image=”” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_repeat=”no-repeat” background_position=”left top” video_url=”” video_aspect_ratio=”16:9″ video_webm=”” video_mp4=”” video_ogv=”” video_preview_image=”” overlay_color=”” overlay_opacity=”0.5″ video_mute=”yes” video_loop=”yes” fade=”no” border_size=”0px” border_color=”” border_style=”” padding_top=”20″ padding_bottom=”20″ padding_left=”” padding_right=”” hundred_percent=”no” equal_height_columns=”no” hide_on_mobile=”no” menu_anchor=”” class=”” id=””][one_third last=”no” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”” padding=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ animation_offset=”” class=”” id=””][/one_third][one_third last=”no” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”” padding=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ animation_offset=”” class=”” id=””][button link=”” color=”custom” size=”large” stretch=”” type=”” shape=”” target=”_self” title=”” gradient_colors=”#49c1a9|#49c1a9″ gradient_hover_colors=”#49c1a9|#49c1a9″ accent_color=”#ffffff” accent_hover_color=”#d1d1d1″ bevel_color=”” border_width=”5px” icon=”” icon_position=”left” icon_divider=”no” modal=”” animation_type=”0″ animation_direction=”left” animation_speed=”1″ animation_offset=”” alignment=”center” class=”” id=””]Apply For Pre-Screening Now[/button][/one_third][one_third last=”yes” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_size=”0px” border_color=”” border_style=”” padding=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ animation_offset=”” class=”” id=””][/one_third][/fullwidth]