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Services
[/vc_column_text][split_line_heading]

Regulatory Affairs Services

[/split_line_heading][/vc_column_inner][vc_column_inner column_padding=”padding-6-percent” column_padding_position=”bottom” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” width=”1/4″ tablet_width_inherit=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none” enable_animation=”true” animation=”fade-in-from-bottom” offset=”vc_col-xs-12″][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row type=”in_container” full_screen_row_position=”middle” scene_position=”center” text_color=”dark” text_align=”left” id=”custom-sub-menu” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none” shape_type=””][vc_column column_padding=”no-extra-padding” column_padding_position=”all” background_color=”rgba(0,0,0,0.01)” background_color_opacity=”1″ background_color_hover=”rgba(0,0,0,0.01)” background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” top_margin=”-150″ width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][page_submenu alignment=”center” sticky=”true”][page_link link_url=”/en/services/clinical-trial-services/” title=”Clinical Trial Services” id=”1763915425219-1″ tab_id=”1763915425220-6″][vc_column_text][/vc_column_text][/page_link][page_link link_url=”/en/services/regulatory-affairs-services/” title=”Regulatory Affairs Services” id=”1763915425263-6″ tab_id=”1763915425264-4″][vc_column_text][/vc_column_text][/page_link][page_link title=”Pharmacovigilance” id=”1763915425286-2″ link_url=”/en/services/pharmacovigilance/” tab_id=”1763915425287-4″][/page_link][page_link title=”Quality assurance” id=”1763915425305-6″ link_url=”/en/services/quality-assurance/” tab_id=”1763915425306-1″][/page_link][page_link title=”Medical Devices Support” id=”1763915425325-9″ link_url=”/en/services/medical-devices-support/” tab_id=”1763915425325-9″][/page_link][page_link title=”Other services” id=”1763915425344-3″ link_url=”/en/services/other-services/” tab_id=”1763915425344-7″][/page_link][page_link title=”GMP/GDP Services” id=”1763915425363-8″ tab_id=”1763915425363-4″ link_url=”https://www.clinres.si/en/services/gmp-and-gdp-services/”][/page_link][/page_submenu][/vc_column][/vc_row][vc_row type=”full_width_background” full_screen_row_position=”middle” scene_position=”center” text_color=”dark” text_align=”left” top_padding=”7%” bottom_padding=”7%” overlay_strength=”0.3″ shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”padding-2-percent” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/2″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text]

Regulatory Affairs Services

[/vc_column_text][team_member image_url=”6251″ team_memeber_style=”meta_below” link_element=”none” color=”Accent-Color” name=”Katja Delić, MSc” job_position=”Head of regulatory affairs department”][vc_column_text]

Our Regulatory Affairs professionals with extensive experience across a full range of regulatory procedures are highly skilled in interfacing with regulatory authorities in all countries where we operate.

We provide our clients with services:

  • of high quality
  • in compliance with regulatory requirements
  • delivered on time

We provide service for all:

  • medicinal products (MPs, DCP, MRP, NP),
  • veterinary medicinal products (VMPs, DCP, MRP, NP),
  • medical devices, food supplements, cosmetics, and biocides.
[/vc_column_text][/vc_column][vc_column column_padding=”padding-2-percent” column_padding_position=”all” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_link_target=”_self” column_shadow=”none” column_border_radius=”none” width=”1/2″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][toggles style=”minimal”][toggle color=”Accent-Color” title=”Submission of Marketing Authorisation Applications”][vc_column_text]Our Regulatory Affairs professionals prepare submissions for:

  • Innovative and generic medicinal products (including biotech)
  • OTC
  • Vaccines
  • Herbal and homeopathic medicinal products
  • Radiopharmaceuticals
  • Blood products and plasma-derived medicinal products
  • Veterinary medicinal products (VMPs)
[/vc_column_text][/toggle][toggle color=”Default” title=”Pre-authorization support”][vc_column_text]Our Regulatory Affairs professionals offer expert advice on submission strategy.[/vc_column_text][/toggle][toggle color=”Default” title=”Expert Reports”][vc_column_text]Our Regulatory Affairs professionals offer preparation of quality (Module 3), non-clinical (Module 2.4) and clinical (Module 2.5) overviews and summaries.

Our Regulatory Affairs professionals offer preparation of safety (as well the ERA report) and residues (Part III) and efficacy (Part IV) expert reports, summaries, and statements for VMPs.[/vc_column_text][/toggle][toggle color=”Default” title=”eCTD format”][vc_column_text]Our Regulatory Affairs professionals offer preparation of marketing authorization application dossiers in:

  • eCTD and Nees format,
  • conversion from exsisting paper and/or electronic CTD or NtA to eCTD or NeeS format,
  • eCTD publishing.
[/vc_column_text][/toggle][toggle color=”Default” title=”Post-approval and submission support”][vc_column_text]Our Regulatory Affairs professionals offer post-approval and submission support:

  • preparation, submission, and management of various applications, renewals, and notifications
  • update and upgrade of documentation
  • translation, preparation, and coordination of information about the product (SmPC, PIL, labelling) in accordance with Slovenian, Croatian, B&H, Serbian, and Macedonian medicinal product legislation
  • marketing materials review, harmonization with approved medicinal products documents
  • communication with authorities (new requirements/answers to deficiency/ clarifications/permissions)
  • preparation of packaging materials (mock-ups/artworks) and proofreading
[/vc_column_text][/toggle][toggle color=”Default” title=”Expert Services for Pricing Submissions”][vc_column_text]Our team of experts provides comprehensive support in the preparation and submission of applications for the determination of the maximum allowed price (NDC) and exceptional higher allowed price (IVDC) of medicinal products.[/vc_column_text][/toggle][toggle color=”Default” title=”Consultancy”][vc_column_text]Our Regulatory Affairs professionals have over 10 years of experience and are willing to provide you with the regulatory advice that you need.[/vc_column_text][/toggle][/toggles][/vc_column][/vc_row]