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    Pharma Services Category of Azidus Laboratories

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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 BioAnalytical Services (1)

    02 Clinical Development / Phase IIb-IV (4)

    03 Compliance, Regulatory & Consulting (1)

    04 Early Clinical / Phase I-IIa (1)

    05 Technology / Data / Analytics (1)

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    01 Azidus Laboratories (8)

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    01 India (8)

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    Azidus Laboratories

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      BIOAVAILABILITY / BIOEQUIVALENCE STUDIES

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      Azidus can undertake several studies such as Single & multiple dose studies, Fasting & Fed studies, PK PD studies, Cross over & parallel studies. BA/BE studies are conducted in extremely controlled environment & all the activities are driven through SOPs.

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      Pharma Service: Clinical Trials

      Category: Clinical Development / Phase IIb-IV

      Sub Category: Bioavailability / Bioequivalence
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        PHARMACOKINETICS / PHARMACODYNAMICS STUDIES

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        Azidus can undertake several studies such as Single & multiple dose studies, Fasting & Fed studies, PK PD studies, Cross over & parallel studies. BA/BE studies are conducted in extremely controlled environment & all the activities are driven through SOPs.

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        Pharma Service: Clinical Trials

        Category: Clinical Development / Phase IIb-IV

        Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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          PHASE II / III STUDIES

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          Azidus has experienced team of professionals to handle all phases of drug development from Phase I to Phase IV clinical trials. The technical team can design & execute the phase trials as per the current International regulatory guidelines.

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          Pharma Service: Clinical Trials

          Category: Clinical Development / Phase IIb-IV

          Sub Category: Phase II / III
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            PHASE IV STUDIES

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            Azidus offers preparation of regulatory dossiers for semi-regulated & regulated markets, preparation of dossiers in CTD format for Market Authorization in various countries, review & preparation of all modules of CTD for regulatory submission.

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            Pharma Service: Clinical Trials

            Category: Clinical Development / Phase IIb-IV

            Sub Category: Phase IV
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              REGULATORY SERVICES

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              Azidus offers preparation of regulatory dossiers for semi-regulated & regulated markets, preparation of dossiers in CTD format for Market Authorization in various countries, review & preparation of all modules of CTD for regulatory submission.

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              Pharma Service: Clinical Trials

              Category: Compliance, Regulatory & Consulting

              Sub Category: Regulatory Affairs
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                BIOANALYTICAL SERVICES

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                We provide quality Bioanalytical services such as development of protocols for Bioanalytical method development, method validation, Method Development & Validation in various mediums like plasma, whole blood, urine & feaces.

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                Pharma Service: Analytical

                Category: BioAnalytical Services

                Sub Category: Overview
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                  CLINICAL DATA MANAGEMENT

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                  We offer comprehensive Clinical Data Management services including Data management plan, Data capture, database designing, Independent double data entry verification, Complete data validation, generation of data validation report & Quality Assurance

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                  Pharma Service: Clinical Trials

                  Category: Technology / Data / Analytics

                  Sub Category: Data Management
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                    PHASE I STUDIES

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                    Azidus has experienced team of professionals to handle the all phases of drug development from Phase I to Phase IV clinical trials. The technical team can design & execute the phase trials at committed time as per the International regulatory guidelines.

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                    Pharma Service: Clinical Trials

                    Category: Early Clinical / Phase I-IIa

                    Sub Category: Phase I / IIa
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