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

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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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    PHARMACOKINETICS & STATISTICAL EVALUATION

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    Specialized software is used for pharmacokinetic and statistical evaluation of study results: SAS® (SAS Institute Inc.,www.sas.com); WinNonlin® Professional (Pharsight Corporation, www.pharsight.com)

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Calculation and Modeling of Pharmacokinetic Parameters
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    PEPTIDE & PROTEIN CHARACTERIZATION

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    According to the ICH-Q6B guidelines, proteins or peptides should be characterized in terms of their visual appearance, molecular weight, isoelectric point, pH in solution, amino acid content, primary structure, and the presence of disulfide bridges.

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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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