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    Pharma Services Category of Nuvisan GmbH

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 Analytical Testing Services (1)

    02 BioAnalytical Services (3)

    03 Clinical Development / Phase IIb-IV (1)

    04 Compliance, Regulatory & Consulting (1)

    05 Early Clinical / Phase I-IIa (2)

    06 Formulation Development (1)

    07 Medical Writing & Language Translation (1)

    08 Packaging & Logistics (1)

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    01 Nuvisan GmbH (11)

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    01 Germany (11)

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    Nuvisan GmbH

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    FORMULATION SUPPORT FOR CLINICAL SUPPLIES

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    Nuvisan supports to accelerate the clinical start by interim oral formulations (powders for constitution, capsules). Nuvisan offers full formulation development for topical, oral liquids & semi-solids e.g. emulsions, gels, liposomal formulations.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Clinical Supply
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    BIOANALYTICAL METHOD DEVELOPMENT & VALIDATION

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    Nuvisan provide Bioanalytical method development & validation. Greater than 500 non proprietary methods developed & validated in a large variety of matrices (plasma, urine, feces, saliva, bile, semen, cerebrospinal fluid, & a variety of solid tissues).

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Method Development and Validation
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    BIOANALYTICAL SERVICES

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    We provide bioanalytical capabilities to support the analysis of both large & small molecules, toxicology studies under full GLP compliance, bioanalytical support for all types of Phase I studies (FIM, PK, PD, Interaction etc.)

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Overview
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    ANALYTICAL TESTING SERVICES

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    Nuvisan is offering pharmaceutical testing under GMP at three sites in Europe. Our Chemical & physical testing parameter includes HPLC-UV, HPLC-Fluorescence, UV-VIS, Titrations, LC-MS, ELISA, Dissolution USP, GC.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Overview
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    BIOAVAILABILITY & BIOEQUIVALENCE STUDIES

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    Nuvisan Clinical Development offers various clinical services including Studies with biologicals, Drug/Drug interaction & Food effect studies, Bioavailability & Bioequivalence Studies, Biosimilar studies, Vaccination studies, Phase IIa studies.

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    Pharma Service: Clinical Trials

    Category: Clinical Development / Phase IIb-IV

    Sub Category: Bioavailability / Bioequivalence
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    CLINICAL DEVELOPMENT SERVICES

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    Nuvisan Clinical Development offers various clinical services including Studies with biologicals, Drug/Drug interaction studies, Food effect studies, Bioavailability & Bioequivalence Studies, Phase IIa, Proof of Concept studies special patient populations

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Phase I / IIa
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    REGULATORY SERVICES

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    Nuvisan provides a wide range of regulatory services such as Regulatory Support to Clinical Trials (IMPDs, Preparation & submission of CTAs) Regulatory Strategy & Development, Preparation of Application Dossiers in CTD format.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Regulatory Affairs
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    DRUG METABOLISM & PHARMACOKINETICS

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    Nuvisan supports you with DMPK/ADME services throughout the discovery & development phases including Tailor-made “phase 0” in vitro & in vivo packages, i.e. in vitro metabolism, CYP interactions, absorption, distribution, PK/ADME in rodents & non-rodents.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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    MEDICAL WRITING

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    Whether you require documents as part of an integrated clinical research package with Nuvisan or as a standalone service, our medical writers can apply their expertise and commitment to the full range of materials at all phases of development.

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    Pharma Service: Clinical Trials

    Category: Medical Writing & Language Translation

    Sub Category: Clinical Research Translation / Validation
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    CLINICAL TRIAL SUPPLIES & LOGISTICS

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    Our Primary packaging services include blisters, bottles, sachets & tubes which are available for solid, semi-solid & liquid bulk products.

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    Pharma Service: Clinical Trials

    Category: Packaging & Logistics

    Sub Category: Clinical Trial Supplies
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    BIOMARKER TESTING SERVICES

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    Nuvisan's Biopharmaceuticals biomarkers testing include immunogenicity testing according to EMA guidelines, cytokine release assays for safety assessment of biologicals, cell based functional assays with various quality standards

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Bioanalytical & Biomarker Testing Services
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