[vc_row type=”full_width_background” full_screen_row_position=”middle” bg_image=”6473″ bg_position=”center center” bg_repeat=”no-repeat” bg_color=”#ffffff” scene_position=”center” text_color=”light” text_align=”left” top_padding=”10%” bottom_padding=”10%” color_overlay=”#000000″ overlay_strength=”0.5″ enable_shape_divider=”true” shape_divider_color=”#ffffff” shape_divider_position=”bottom” shape_divider_height=”100″ bg_image_animation=”none” parallax_bg=”true” parallax_bg_speed=”fast” shape_type=”mountains”][vc_column centered_text=”true” column_padding=”no-extra-padding” 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=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” column_border_width=”none” column_border_style=”solid” bg_image_animation=”none”][vc_column_text css_animation=”fadeInUp” css=”.vc_custom_1567530219179{margin-bottom: 15px !important;}”]

Experience

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Clinical trials – track record

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Clinres Farmacija has the resources to excel in a wide range of projects – from small local studies to complex, multi-sponsor, and multi-national programs.

Expertise in common areas:

   Oncology

   Endocrinology/Metabolism

   Cardiology

Expertise in specific and rare fields:

   Pulmonary hypertension in newborns

   Chronic lymphocytic leukemia

   Chronic hepatitis C

   New SMA treatments in children and adults.

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Global PV services:

   EU QPPV

   Development, adaptation, implementation, and maintenance of the global PV system

   Global literature screening

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Local PV services:

   Local QPPV/contact person

   Expert advice on local PV requirements

   Development, adaptation, implementation, and maintenance of the local PV system

   Local literature screening

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Pharmacovigilance

We are offering both global and local pharmacovigilance services.

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Regulatory affairs

Our Regulatory Affairs Professionals have extensive experience across the full range of regulatory procedures and are highly skilled in collaborating with regulatory authorities in the countries where we operate.

We provide clients with high quality services, delivered on time, and in compliance with regulatory requirements.

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Services we cover:

   Pre-authorisation Support

   Submission of marketing authorization applications

   Expert reports

   eCTD format

   Post-approval and submission support

   Consultancy

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We provide service for:

   Medicinal products (CP, DCP, MRP, NP)

   Veterinary medicinal products (CP, DCP, MRP, NP)

   Medical devices

   Food supplements

   Cosmetics

   Biocides

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Check all the services, we provide.

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