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    Pharma Services Category of Prague Scientific

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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 API Development (8)

    02 Analytical Method Development (1)

    03 Analytical Testing Services (1)

    04 Capsule (1)

    05 Clinical Development / Phase IIb-IV (1)

    06 Compliance, Regulatory & Consulting (1)

    07 Cream / Lotion / Ointment (1)

    08 Formulation Development (6)

    09 GMP Manufacturing (1)

    10 Injectable / Parenteral (1)

    11 Liquid (1)

    12 Medical Writing & Language Translation (1)

    13 Post Marketing (1)

    14 Preformulation & Material Science (4)

    15 Solution (1)

    16 Spray (1)

    17 Suspension (1)

    18 Tablet (2)

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    01 Prague Scientific (34)

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    01 Czech Republic (34)

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    Prague Scientific

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    ROUTE SCOUTING SERVICES

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    Prague Scientific performs a literature search to establish current state-of-the art routes and to identify synthetic route options, including novel routes. It provides optimization on a small scale to select the most promising synthetic route.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Route Scouting
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    SOLID FORM DEVELOPMENT

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    Prague Scientific provides screening and process development services for crystalline forms (polymorphs, hydrates, solvates, salts, cocrystals) and amorphous forms (amorphous APIs, co-amorphs and solid solutions by precipitation & hot melt extrusion).

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Solid State Characterization
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    API PROCESS DEVELOPMENT & OPTIMIZATION

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    Prague Scientific offers process development & GMP operations with optimization of chemical reaction parameters utilizing DoE & QbD principles, as well as process validation of development APIs for clinical trials & commercial supply.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Development & Optimization
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    API SCALE-UP

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    Prague Scientific manufactures commercial APIs in the Prague kilolab, Ankleshwar (India) Pilot plant. It has various equipment available such as reactors 25-2500L, autoclaves 20-630L, isolation & drying units, milling equipment, spray dryer, etc.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Scale-Up Capabilities
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    PARTICLE SIZE MODIFICATION

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    Prague Scientific offers particle size modification, API solubility enhancement systems, screening and process development of crystalline and amorphous forms.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Particle Size Reduction & Micronization
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    ANALYTICAL DEVELOPMENT

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    Prague Scientific offers analytical method development, validation and transfer, specification setting, stability and stress testing, CMC and dossier preparation.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Method Development and Validation
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    OLIGONUCLEOTIDE SYNTHESIS

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    Prague Scientific offers synthesis, purification, characterisation and analysis of oligonucleotides.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Protein / Peptide
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    GMP OPERATIONS FOR COMMERCIAL MANUFACTURING

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    Prague Scientific offers process development & GMP operations with optimization of chemical reaction parameters utilizing DoE & QbD principles, as well as process validation of development APIs for clinical trials & commercial supply.

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    Pharma Service: API Manufacturing

    Category: GMP Manufacturing

    Sub Category: Overview
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    PREFORMULATION AND COMPOSITION OPTIMIZATION

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    Prague Scientific offers API and powder characterization & reference product characterization involving reverse engineering of solid dosage form products and investigation of key characteristics using scanning electron microscopy and hot-stage microscopy.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Overview
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    FORMULATION DEVELOPMENT OF TABLETS

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    Prague Scientific offers formulation development for solid oral tablets with immediate, modified & delayed release. It has various technologies, including direct compression, encapsulation, dry & wet granulation, Wurster coating, etc.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Tablet
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    FORMULATION DEVELOPMENT OF CAPSULES

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    Prague Scientific offers formulation development for various drug delivery dosage forms, such as solid oral capsules with immediate release, modified release, delayed release, multi-unit delivery systems (pellets), etc.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Capsule
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    ORAL SUSPENSION DEVELOPMENT

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    Prague Scientific offers formulation development for various drug delivery dosage forms, such as oral suspensions and solutions.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Suspension
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    INJECTABLE SOLUTION & SUSPENSION DEVELOPMENT

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    Prague Scientific offers formulation development for various drug delivery dosage forms, such as injection solutions, suspensions, etc. It provides an injectable ampoule or vial filling line under a nitrogen atmosphere.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Injectable / Parenteral
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    STERILE AND NON-STERILE OINTMENTS

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    Prague Scientific offers finished dosage form production, including solid dosage forms, sterile and non-sterile ointments, sterile injectables, hormone solid dosage forms, etc.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Cream / Gel / Lotion / Ointment
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    CONTRACT MANUFACTURING FOR CAPSULES

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    Prague Scientific offers contract manufacturing of various oral solid dosage forms, such as hard gelatin capsules, with production capacities ranging from 70 kg to 1,000 kg.

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    Pharma Service: Drug Product Manufacturing

    Category: Capsule

    Sub Category: Overview
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    CONTRACT MANUFACTURING FOR ORAL LIQUIDS

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    Prague Scientific offers contract manufacturing of oral liquid dosage forms as drops, with a production capacity of up to 1,500 kg.

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    Pharma Service: Drug Product Manufacturing

    Category: Liquid

    Sub Category: Overview
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    SUSPENSION CONTRACT MANUFACTURING

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    Prague Scientific offers contract manufacturing of oral liquid dosage forms, such as suspensions, with a production capacity of up to 1,500 kg.

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    Pharma Service: Drug Product Manufacturing

    Category: Suspension

    Sub Category: Overview
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    NASAL & TOPICAL SPRAYS

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    Prague Scientific offers contract manufacturing of liquid dosage forms, such as nasal and topical sprays and otic drops, with a production capacity of up to 500 kg.

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    Pharma Service: Drug Product Manufacturing

    Category: Spray

    Sub Category: Overview
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    CONTRACT MANUFACTURING FOR OPHTHALMICS

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    Prague Scientific offers contract manufacturing of sterile ophthalmic drops with the production scale of 5, 10 & 15 ml.

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    Pharma Service: Drug Product Manufacturing

    Category: Solution

    Sub Category: Ophthalmic
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    HORMONE ORAL SOLID MANUFACTURING

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    Prague Scientific offers contract manufacturing of solid dosage forms (hormones), including film-coated tablets and capsules.

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    Pharma Service: Drug Product Manufacturing

    Category: Tablet

    Sub Category: Steroid / Hormone
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    CONTRACT MANUFACTURING FOR INJECTABLES

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    Prague Scientific offers contract manufacturing of parenteral liquid dosage forms, including ampoules and vials.

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    Pharma Service: Drug Product Manufacturing

    Category: Injectable / Parenteral

    Sub Category: Overview
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    CONTRACT MANUFACTURING FOR SEMI-SOLIDS

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    Prague Scientific offers contract manufacturing of semi-solid dosage forms, including topical gels, creams and ointments (sterile and non-sterile).

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    Pharma Service: Drug Product Manufacturing

    Category: Cream / Lotion / Ointment

    Sub Category: Overview
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    TABLET CONTRACT MANUFACTURING

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    Prague Scientific offers contract manufacturing of oral solid dosage forms, including tablets, film-coated tablets, tongue-soluble tablets, chewable tablets, etc.

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    Pharma Service: Drug Product Manufacturing

    Category: Tablet

    Sub Category: Overview
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    SOLID FORM CHARACTERIZATION

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    Prague Scientific offers solid-form characterization, including X-ray powder diffraction, infrared and Raman spectroscopy, differential scanning calorimetry, and solid-state nuclear magnetic resonance.

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    Pharma Service: API & Drug Product Development

    Category: Preformulation & Material Science

    Sub Category: Solid State Characterization
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    ROUTE EVALUATION SERVICES

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    Prague Scientific identifies synthetic routes options including designing novel routes. It provides laboratory assessment and optimization on a small scale to select the most promising synthetic route including preparation of standards of impurities.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Route Evaluation & Development
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    PROCESS SAFETY DATA MEASUREMENT

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    Prague Scientific performs optimization of chemical reaction parameters utilizing Design of Experiments (DoE) & Quality by Design (QbD) principles (e.g. Cost of goods manufactured, yield, cycle time, quality etc.) with process safety data measurement.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Process Safety Assessment
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    API FOR CLINICAL SUPPLY

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    Prague Scientific offers development of active pharmaceutical ingredients (APIs) for clinical trials and commercial supply.

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Clinical Supply
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    NITROSAMINE IMPURITY TESTING

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    Prague Scientific offers evaluation and method development for various nitrosamines impurities, genotoxic impurities in API, drug product and excipients.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Impurity Isolation and Identification
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    FULL SCALE PHARMACOVIGILANCE SERVICES

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    From early-stage development through the approval & launch of new products, Prague Scientific can assist with all regulatory needs across the entire product lifecycle. It offers full scale pharmacovigilance services with MA maintenance.

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    Pharma Service: Clinical Trials

    Category: Post Marketing

    Sub Category: Pharmacovigilance / Product Lifecycle Management
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    REGULATORY SUPPORT

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    From early-stage development through the approval and launch of new products, Prague Scientific's regulatory experts can assist with all regulatory needs across the entire product lifecycle.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Overview
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    MEDICAL WRITING

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    Prague Scientific offers medical writing services along with clinical and preclinical development plan, pilot and pivotal study design (PK, BES, PD, efficacy/safety), CRO qualification, etc.

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    Pharma Service: Clinical Trials

    Category: Medical Writing & Language Translation

    Sub Category: Overview
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    PK & PD ANALYSIS

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    Prague Scientific conducts pilot & pivotal study design (PK, BES, PD, efficacy/safety), in vitro in vivo relationship, CRO qualification, selection by tender process and monitoring, study results evaluation & troubleshooting with medical writing services.

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    Pharma Service: Clinical Trials

    Category: Clinical Development / Phase IIb-IV

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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    MODIFIED RELEASE FORMULATION DEVELOPMENT

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    Prague Scientific offers formulation development of oral solids such as immediate release, modified release, delayed release tablets and capsules with multi unit delivery systems (pellets).

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Controlled / Immediate / Modified Release
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    NITROSAMINE IMPURITY SYNTHESIS & ANALYSIS

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    Prague Scientific offers synthesis and analytical characterization of nitrosamine standards with confirmatory nitrosamine testing on the ppb/ppm level (analytical method development and validation).

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    Pharma Service: API & Drug Product Development

    Category: API Development

    Sub Category: Impurity / Reference Standard
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