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    Pharma Services Category of QUINTA-ANALYTICA s.r.o

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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 (5)

    02 Analytical Testing Services (30)

    03 BioAnalytical Services (7)

    04 Clinical Development / Phase IIb-IV (1)

    05 Clinical Services (2)

    06 Stability Studies (5)

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    01 QUINTA-ANALYTICA s.r.o (50)

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    01 Czech Republic (50)

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    QUINTA-ANALYTICA s.r.o

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    ICH STABILITY STUDIES

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    We perform ICH stability studies on drug substance and /or dosage form. Studies are conducted according to the Stability Study Protocols and fully under GMP conditions.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    STABILITY STUDIES

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    Since its foundation, Quinta-Analytica has been providing a complete service of stability studies with active substances and dosage forms. Also these studies are conducted within the GMP framework and according to the ICH guidelines.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    BIOEQUIVALENCE STUDIES / STUDIES I-IV PHASE

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    Quinta has many years of experience in pharmacokinetic/bioequivalence studies. We provide a complete study on healthy volunteers. Our activities include clinical area, bioanalytical area, evaluation and QA/QC.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Overview
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    BIOANALYTICAL - PHARMACOKINETIC EVALUATION

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    Quinta is a bioanalytical CRO offering pharmaceutical analysis & bioanalytical contract services. It offers bioanalytical testing services for biosimilars, peptides, proteins & large molecules followed by their pharmacokinetic & statistical evaluation.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Calculation and Modeling of Pharmacokinetic Parameters
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    BIOANALYTICAL - PEPTIDE CHARACTERIZATION

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    Quinta is a bioanalytical CRO that offers pharmaceutical analysis & bioanalytical testing services. Its bioanalytical contract services include bioanalytical method development, and characterization of peptides, proteins, biosimilars, and large molecules.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Structural Characterization
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    METHOD TRANSFER & VALIDATION

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    Methods transfers are performed according to the GMP procedures and approved method transfer protocols. Similarly, method validations are also strictly performed according to the GMP procedures and approved validation protocols.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    ANALYSIS OF HIGHLY POTENT SUBSTANCES

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    We use our Highly Potent Substance Laboratory (HPSL) for highly potent products like cytostatics hormones and antibiotics within a hygienic loop, equipped with dedicated equipment and specially trained personnel.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: High Potency APIs (HPAPIs)
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    QUALITY CONTROL & RELEASE TESTING

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    Quinta-Analytica is a well-known and established company performing so called „import testing“. This is a testing of a batch manufactured outside EU which is planned for import and release within European market.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Batch Release and Stability Lot Testing
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    MANUFACTURING PROCESS VALIDATION

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    Manufacturing validation of the finished dosage form is the one of the most important processes in the GMP production. Manufacturing process has to be validated under GMP.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Overview
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    ANALYSES OF INHALATION PRODUCTS

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    As new unique Quinta-Analytica’s speciality, a laboratory for testing dry powder inhalation products (in inhalation devices) is now in full operation.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Inhalation Products
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    LC / MS & GC / MS METHODS FOR TRACE ANALYSIS

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    We are skilled in the development of analytical methods for determination of trace amounts of tracked impurities. We usually develop methods for assessment of toxic impurities at levels much below those demanded by corresponding regulatory authorities.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Impurity Isolation and Identification
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    STRUCTURE ELUCIDATION OF IMPURITIES

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    An identification and structural elucidation of impurities represents a frequent task which we deal with.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Structure Elucidation
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    ISOLATION OF SELECTED COMPONENTS

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    We use either a classical low-pressure column chromatography or HPLC on our automated semi-preparative modular HPLC system (Waters).

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Impurity Isolation and Identification
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    VARIOUS HPLC & UPLC SYSTEMS

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    TLC SYSTEM - VIDEOSTORE, VIDEOSCAN - CAMAG

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    GC/HEADSPACE - AGILENT/CTC COMBIPAL

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    2 ION CHROMATOGRAPH - DIONEX

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    ICP/MS - AGILENT 7800

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Mass Spectrometry and GC / MS
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    OFFLINE DISSOLUTION

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Dissolution
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    ONLINE DISSOLUTION WITH HPLC

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Dissolution
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    4 UVA/IS - VARIAN (FLOW CELL), SHIMADZU

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: UV Spectrophotometry
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    FT/IR - NICOLET, POLARIMETER - PERKIN-ELMER

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: FTIR / NIR
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    PARTICLE SIZER - LASER - MS 3000, MALVERN

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Particle Size
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    MICROSCOPE/IMAGE ANALYSIS - OLYMPUS

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Light Microscopy
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    FRIABILATOR - VANKEL

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Friability
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    HARDNESS TESTER - VANKEL

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Hardness
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    DISINTEGRATOR - VANKEL

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Disintegration
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    GC / FID, GC / MS (QUADRUPOLE)

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    GC/FID, GC/MS (quadrupole) with liquid injection, static and dynamic headspace injection, PTV injection, on column injection; El, Cl ionization - Agilent, /CTC CombiPal.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Mass Spectrometry and GC / MS
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    (U)HPLC/MSN , FLOW INJECTION MS

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    (U)HPLC/MSn , flow injection MS; Ionization methods: ESI(HESI), APCI, APPImass analyzers: linear ion trap, QQQ, Orbitrap - Thermo

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Mass Spectrometry and GC / MS
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    TLC WITH AUTO SPOTTING & UV/VIS DETECTION

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. TLC with automatic spotting and UV/VIS detection with a CCD camera and quantification software - Camag

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    Pharma Service: Analytical

    Category: Analytical Testing Services

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

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    TSQ Altis (two-channel UHPLC, sensitivity up to 100 fg/mL of plasma); 3 TSQ Quantiva (all with two-channel HPLC); 4 TSQ Vantage (2 with two-channel HPLC); TSQ Quantum. Capacity up to 3750 analytical runs per day.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: LC - MS - MS
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    ACQUITY UPLC (WATERS)

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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    GEL ELECTROPHORESIS BIO RAD

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Native Gel Electrophoresis
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    WESTERN BLOT (BIO-RAD)

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Immunoassay & Cell Based Assay
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    ELISA READER (BIOTEK)

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Immunoassay & Cell Based Assay
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    AMINO ACID ANALYZER (SYKAM)

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Amino Acid Analysis
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    STABILITY CABINETS

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Stability Cabinets - temperature/humidity/light exposure testing compliant with ICH guidelines.

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    Category: Stability Studies

    Sub Category: Overview
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    STABILITY CHAMBERS

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    Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Stability Chambers - 25°C/60%; 30°C/65%; 30°C/75%, 40°C/75%, 5°C and others compliant with ICH guidelines.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    CAPILLARY ELECTROPHORESIS METHOD DEVELOPMENT

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    Quinta-Analytica operating in full compliance with GCP/GLP/GMP and FDA standards. Quinta offers capillary electrophoresis analytical method development services and capillary electrophoresis method development for pharmacopoeial drugs.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Capillary Electrophoresis
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    PROTEIN PURITY TESTING

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    Quinta is a capillary electrophoresis service provider for analytical testing & works in line with GLP and GCP guidelines. Quinta offers protein purity testing by capillary electrophoresis, glycosylation oxidation capillary electrophoresis services etc.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Capillary Electrophoresis
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    AMINO ACID TESTING

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    Quinta is one of the capillary electrophoresis service providers for analytical testing. It offers amino acid testing by capillary electrophoresis, glycosylation capillary electrophoresis services, oxidation capillary electrophoresis services.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Capillary Electrophoresis
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    PROTEIN TESTING BY CAPILLARY ELECTROPHORESIS

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    Quinta is one of the capillary electrophoresis service providers for analytical testing. It offers protein testing by capillary electrophoresis, protein characterization using capillary electrophoresis, glycosylation and oxidation capillary electrophoresis services etc.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Capillary Electrophoresis
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    PEPTIDE TESTING BY CAPILLARY ELECTROPHORESIS

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    Quinta, one of the capillary electrophoresis service providers for analytical testing offers peptide testing & protein purity testing by capillary electrophoresis, glycosylation capillary electrophoresis services, ETC

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Capillary Electrophoresis
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    PHARMACEUTICAL ANALYSIS OF PROTEINS

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    Quinta is a CRO for bioanalytical services offering pharmaceutical analysis for proteins and peptides characterization. Its bioanalytical contract services include bioanalytical method development and quality control for biosimilars & large molecules.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Capillary Electrophoresis
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    PEPTIDE CHARACTERIZATION

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    Our biopharmaceutical analyses offers services that include protein and peptide characterization, validation of bioanalytical methods in the GxP environment, method transfers, QC and release testing in accordance with the recommendations of ICH-Q6B.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Capillary Electrophoresis
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    PHOTOSTABILITY STUDIES

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    Quinta-Analytica has been providing a complete service of stability studies with active substances and dosage forms. Also these studies are conducted within the GMP framework and according to the ICH guidelines with photostabiity chambers

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Photostability
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    ANALYTICAL METHOD DEVELOPMENT

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    Methods transfers are performed according to the GMP procedures and approved method transfer protocols. Similarly, method validations are also strictly performed according to the GMP procedures and approved validation protocols.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Overview
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    PHASE I CLINICAL TRIALS & BE/BA STUDY

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    Phase I, namely BA and BE in healthy volunteers ~1000 square meters clinical department comprising 60 beds in two independent units. Dosing sessions in large groups (up to 60 subjects in parallel). GCP/GLP compliant. 16,000+ volunteers database.

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    Pharma Service: Clinical Trials

    Category: Clinical Development / Phase IIb-IV

    Sub Category: Bioavailability / Bioequivalence
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    GMP SECONDARY PACKAGING FOR CLINICAL TRIALS

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    Department of Packaging is a separate unit within Quinta-Analytica dealing with primary and secondary packaging in small scale of the solid dosage forms into blisters/strips or containers for research purposes, for clinical trials, and stability studies.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Secondary Packaging
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    SMALL SCALE SOLID DOSAGE FORMS

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    Department of Packaging is a separate unit within Quinta-Analytica dealing with primary and secondary packaging in small scale of the solid dosage forms into blisters/strips or containers for research purposes, for clinical trials, and stability studies.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Overview
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