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    Pharma Services Category of Primera Analytical Solutions Corp

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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 Method Development (2)

    02 Analytical Testing Services (4)

    03 Extractables and Leachables (1)

    04 Stability Studies (1)

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    01 Primera Analytical Solutions Corp (8)

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    01 U.S.A (8)

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    Primera Analytical Solutions Corp

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    STABILITY STUDIES

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    Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    ASSESSMENT OF LEACHABLES & EXTRACTABLES IN DRUG PRODUCT...

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    Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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    Pharma Service: Analytical

    Category: Extractables and Leachables

    Sub Category: Testing Services
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    CHIRAL SEPARATION

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    Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Chiral HPLC & SFC Method Development
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    DRUG SUBSTANCE IMPURITY PROFILES

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    - Service Details

    Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Impurity Isolation and Identification
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    COULOMETRIC & VOLUMETRIC KARL FISCHER TESTING

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    Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Karl Fischer / Water Analysis
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    HEAVY METAL ANALYSIS BY ICP/MS

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    Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Trace / Elemental / Heavy Metals
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    RESIDUAL SOLVENTS

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    Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Residual Solvents
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    CLEANING VALIDATION

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    - Service Details

    Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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