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    Pharma Services Category of RegPak BioPharma

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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 Active Pharmaceutical Ingredients (3)

    02 Compliance, Regulatory & Consulting (1)

    03 Dietary Supplements (Nutraceuticals) (1)

    04 Medical Devices (1)

    05 Regulatory Affairs / Pharmacovigilance (6)

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    01 RegPak BioPharma (12)

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    01 Netherlands (12)

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    RegPak BioPharma

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      STRATEGIC PLANNING FOR PRODUCT DEVELOPMENT

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      - Service Details

      RegPak BioPharma is a full service Regulatory Affairs Consultancy with the key objective of providing high quality services within Regulatory Affairs, Licensing and Technical Services to the industries.

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      Pharma Service: Sales, Marketing, Registration

      Category: Active Pharmaceutical Ingredients

      Sub Category: Netherlands
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        GLOBAL REGULATORY INTELLIGENCE

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        - Service Details

        RegPak helps preparation/ leading preparation of various modules for MAA & licence Maintenance incl. variations,  CTA applications, orphan drug designation, CE marking technical file.

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        Pharma Service: Sales, Marketing, Registration

        Category: Active Pharmaceutical Ingredients

        Sub Category: Netherlands
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          PRODUCT PROMOTION & LABELLING

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          - Service Details

          RegPak helps development and maintenance of Company Core Data Sheet, SmPC and PIL 

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          Pharma Service: Sales, Marketing, Registration

          Category: Active Pharmaceutical Ingredients

          Sub Category: Netherlands
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            PHARMACOVIGILANCE

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            - Service Details

            RegPak provides RMP, PSUR, PSMF, Pharmacovigilance planning, QPPV services

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            Pharma Service: Sales, Marketing, Registration

            Category: Regulatory Affairs / Pharmacovigilance

            Sub Category: Netherlands
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              QA & INSPECTIONS

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              RegPak provides assistance with regulatory and GMP audits/Inspections

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              Pharma Service: Sales, Marketing, Registration

              Category: Regulatory Affairs / Pharmacovigilance

              Sub Category: Netherlands
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                REGULATORY DUE DILIGENCE ON NEW PRODUCT OPPORTUNITIES

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                - Service Details

                RegPak helps developing and executing pricing and reimbursement strategies for new products. Refining strategies for in-line products

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                Pharma Service: Sales, Marketing, Registration

                Category: Regulatory Affairs / Pharmacovigilance

                Sub Category: Netherlands
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                  PRICING & REIMBURSEMENT

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                  RegPak helps developing and executing pricing and reimbursement strategies for new products. Refining strategies for in-line products

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                  Pharma Service: Sales, Marketing, Registration

                  Category: Regulatory Affairs / Pharmacovigilance

                  Sub Category: Netherlands
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                    SCIENTIFIC DATA ASSESSMENT

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                    - Service Details

                    RegPak assesses the liability risks of pharmaceutical regulation, registration, products and services represents a unique challenge.

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                    Pharma Service: Sales, Marketing, Registration

                    Category: Regulatory Affairs / Pharmacovigilance

                    Sub Category: Netherlands
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                      REGISTRATION

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                      - Service Details

                      Regpak's regulatory consulting staff can provide you with support during both preclinical and clinical development, manufacturing, product licensing, and regulatory approvals.

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                      Pharma Service: Sales, Marketing, Registration

                      Category: Regulatory Affairs / Pharmacovigilance

                      Sub Category: Netherlands
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                        CLINICAL CONSULTANCY

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                        - Service Details

                        RegPak has extensive experience of the preparation, submission and approval process for clinical trial applications in major clinical trial conducting countries.

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                        Pharma Service: Clinical Trials

                        Category: Compliance, Regulatory & Consulting

                        Sub Category: Consulting Services
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                          CONSULTING SERVICES FOR MEDICAL DEVICES

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                          RegPak BioPharma provides a full range of consulting services for the development and registration of medical devices

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                          Category: Medical Devices

                          Sub Category: Netherlands
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                            CONSULTING SERVICES FOR NUTRITIONAL & FOOD SUPPLEMENT

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                            - Service Details

                            RegPak BioPharma provides expert opinion and advice in the areas of technology evaluation / due diligence in nutraceuticals and food supplement product approval.

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                            Pharma Service: Sales, Marketing, Registration

                            Category: Dietary Supplements (Nutraceuticals)

                            Sub Category: Netherlands
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