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    Pharma Services Category of PCI Pharma Services

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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 (1)

    02 Analytical Testing Services (1)

    03 Clinical Services (18)

    04 Contract Services (1)

    05 Formulation Development (10)

    06 Packaging & Logistics (1)

    07 Stability Studies (1)

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    01 PCI Pharma Services (33)

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    01 U.S.A (33)

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    PCI Pharma Services

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    FILM COATED TABLETS FOR CLINICAL DEVELOPMENT

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    Equipped to meet the needs of development and small batch requirements, PCI's CDMO facility is scaled to develop & manufacture up to 10kg batches of film coated tablets for clinical development.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Tablet
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    CAPSULE FORMULATION DEVELOPMENT

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    Equipped to meet the needs of development and clinical batch requirements, our development facility is scaled to produce up to 10kg batches of capsules.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Capsule
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    POWDER FORMULATION DEVELOPMENT

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    PCI offers formulation development services for a variety of dosage forms including powders.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Powder / Blend
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    GEL AND CREAM FORMULATION DEVELOPMENT

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    PCI offers formulation development services for a variety of dosage forms including gels and creams.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Cream / Gel / Lotion / Ointment
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    LIQUIDS, SOLUTION FORMULATION DEVELOPMENT

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    PCI offers formulation development services for a variety of dosage forms including liquids, solutions.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Liquid Formulation
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    SUSPENSION FORMULATION DEVELOPMENT

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    PCI offers formulation development CDMO services for a variety of solid & liquid oral dosage forms including suspensions.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Suspension
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    EMULSION FORMULATION DEVELOPMENT

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    PCI offers formulation development services for a variety of dosage forms including emulsions.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Emulsion
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    SUPPOSITORY AND PESSARY FORMULATION DEVELOPMENT

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    PCI offers formulation development services for a variety of dosage forms including suppositories and pessaries.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Vaginal / Rectal
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    GRANULES FOR RECONSTITUTION FORMULATION DEVELOPMENT

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    PCI offers formulation development services for a variety of dosage forms including granules for reconstitution.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Granule / Pellets
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    LIQUIDS FOR STERILIZATION FORMULATION DEVELOPMENT

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    PCI offers formulation development services for a variety of dosage forms including liquids for sterilizatio.

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    Pharma Service: API & Drug Product Development

    Category: Formulation Development

    Sub Category: Injectable / Parenteral
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    STABILITY STORAGE & TESTING

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    PCI features fully audited, in-house laboratories in both our European and North America locations offering a range of analytical services to support clients in the development and commercialization of new medicines.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Overview
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    GMP AND ICH COMPLIANT METHOD DEVELOPMENT & VALIDATION

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    GMP and ICH compliant analytical equipment enabling our teams to perform simple ID testing and analytical method transfers, through method development and validation, to EU product release and ICH stability testing, ensuring data reliability and regulatory compliance.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Overview
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    ANALYSIS OF CYTOTOXIC & HIGH POTENT APIs

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    Our facilities also include HEPA filtered air handling systems for the analysis of cytotoxic, teratogenic and uncharacterised products, a darkroom for the analysis of light sensitive products, and have the capabilities to work with Schedule II-IV controlled substances.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: High Potency APIs (HPAPIs)
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    SECONDARY PACKAGING - TYVEK BLISTERING FOR PARENTERALS

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    Precision labeling technologies support parenteral applications including vials and ampoules, syringes and injectable devices, as well as transdermals and eye care applications.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Secondary Packaging
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    SECONDARY PACKAGING - OVERWRAPPING & POUCHING

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    Precision labeling technologies support parenteral applications including vials and ampoules, syringes and injectable devices, as well as transdermals and eye care applications.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Secondary Packaging
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    SECONDARY PACKAGING - WALLETING

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    Precision labeling technologies support parenteral applications including vials and ampoules, syringes and injectable devices, as well as transdermals and eye care applications.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Secondary Packaging
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    CLINICAL TRIAL PACKAGING

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    At PCI we combine knowledge, experience, and innovative technologies to provide our customers packaging services that ensure safety and reliability throughout.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Overview
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    CLINICAL TRIAL PRIMARY PACKAGING

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    PCI's primary packaging capabilities feature scalable options to meet the varying needs of each trial, from small Phase I studies to the largest Phase III and Phase IV programs.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Overview
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    PRIMARY PACKAGING - BLISTERING

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    PCI features several form-fill-seal platforms capable of supporting thermo-formed and cold-formed (foil-foil) blister packaging. Our lines are equipped with on-line vision inspection to ensure fill accuracy for every cavity including multiple product fill

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Blister
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    PRIMARY PACKAGING - BOTTLING

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    PCI's bottle fill technologies support both small-scale and large-scale clinical trials. Lines are equipped to handle solid oral doses including tablets, capsules, and softgels as well as precise powder filling.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Bottle
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    PRIMARY PACKAGING - POUCHING / SACHET FILLING

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    PCI offers horizontal overwrapping solutions for both primary and secondary packaging applications.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Pouch / Sachet / Stick Pack
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    PRIMARY PACKAGING - TUBE FILLING

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    PCI's small and large-scale tube filling is offered for topical delivery forms, accommodating liquids, gels, creams, and ointments.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Tube
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    CLINICAL TRIAL SECONDARY PACKAGING

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    PCI offers a host of pharmaceutical secondary packaging solutions ensuring the most effective solution for the specific needs of the patient and trial.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Secondary Packaging
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    SECONDARY PACKAGING - COMPLIANCE PROMPTING

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    PCI offers multiple compliance prompting packaging formats to best address the needs of clinical trials, including ancillary compliance supporting materials. Our in-house design team works closely with clients to create the optimal solution to address pat

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Compliance Packaging
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    SECONDARY PACKAGING - CHILD RESISTANT

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    PCI features many F=1 Child Resistant / Senior Friendly solutions including our proprietary line of packaging including IntuiDose, IntuiPac, DuraPac, AssuraDose, RxBarrier, HingePak, and Compliance in a Bottle (CIAB).

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Compliance Packaging
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    SECONDARY PACKAGING - PARENTERAL LABELING

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    Precision labeling technologies support parenteral applications including vials and ampoules, syringes and injectable devices, as well as transdermals and eye care applications.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Label
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    SECONDARY PACKAGING & KITTING

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    Patient kits are organized and assembled with precision, ensuring the correctness of contents and location of individual components. Inspections ensure that each and every kit produced meets established standards for patient use.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Secondary Packaging
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    SECONDARY PACKAGING - DEVICE ASSEMBLY

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    PCI offers sophisticated assembly solutions for even the most complex package assembly, including unique devices for injection or inhalation. Best-in-class technologies ensure complex assemblies are constructed to exacting quality standards.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Secondary Packaging
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    SECONDARY PACKAGING - STERILE APPLICATIONS

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    PCI features solutions for device packaging, including rigid and flexible packaging delivery, as well as turnkey sterilization services. PCI supports multi-stage packaging assemblies including complex kitting.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Secondary Packaging
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    CLINICAL TRIAL PACKAGING - PACKAGE DESIGN & DEVELOPMENT

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    PCI offers package design solutions for early stage development through successful launch execution, supporting both oral and parenteral delivery forms.

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: Design
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    CLINICAL TRIAL PACKAGING - SPECIALTY PRODUCT PACKAGING

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    PCI is able to offer packaging solutions for unique products, with segregated suites and facilities for those products requiring special handling including Potent Packaging, Cold Chain, Biologics and Advanced Therapeutic Medicinal Products (ATMPs).

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    Pharma Service: Packaging

    Category: Clinical Services

    Sub Category: High Potent / Biologic / Controlled Substance
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    SECONDARY PACKAGING - POTENTS, CONTROLLED SUBSTANCES

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    Precision labeling technologies support parenteral applications including vials and ampoules, syringes and injectable devices, as well as transdermals and eye care applications.

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    Pharma Service: Packaging

    Category: Contract Services

    Sub Category: High Potent / Biologic / Controlled Substance
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    PACKAGING LABEL DESIGN

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    PCI Pharma Services provide clinical trial packaging & labeling involving comprehensive packaging service including packaging design and development. They blend extensive label design technology with flexible primary and secondary packaging.

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    Pharma Service: Clinical Trials

    Category: Packaging & Logistics

    Sub Category: Packaging Design & Development
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