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  • Product Areas
    • Medicinal Products
      • Taking Responsibility
        • Marketing Authorisation Holder
          Marketing Authorisation Holder

          Diapharm assumes the role of the marketing authorisation holder on behalf of manufacturers and distributors.

        • Qualified Person for Pharmacovigliance
          Qualified Person for Pharmacovigliance

          Every pharmaceutical company in Germany is required to appoint a Qualified Person for Pharmacovigilance (QPPV) with the competent authority.
           

        • Information Officer
          Information Officer
        • Batch Release & Qualified Person
          Batch Release & Qualified Person

          Within Diapharm's manufacturing and import authorisation, Qualified Persons carry out the batch release of medicinal products. 

        Taking Responsibility

        Diapharm provides information officers, graduated plan officers, qualified persons, and manufacturing functions.

        See Overview

      • Regulatory Affairs
        • Marketing Authorisation
          Marketing Authorisation

          Diapharm develops an appropriate marketing authorisation strategy, taking into account the various procedures.

        • eCTD Dossier
          eCTD Dossier

          For existing documentation, Diapharm takes care of maintenance and the necessary (re-)formatting into the eCTD/CTD format.

        • Environmental Risk Assessment
          Environmental Risk Assessment
        • Readability User Test
          Readability User Test

          A prerequisite for marketing authorisation is the conduct of readability tests to ensure that patients understand the package leaflet.

        • Rx to OTC Switch
          Rx to OTC Switch

          Diapharm advises and supports clients in the planning, strategic approach, and implementation of Rx-to-OTC switches.

        • Due Diligence
          Due Diligence

          Regulatory due diligence is the regulatory assessment of investment decisions in the healthcare products industry.

        Regulatory Affairs

        Together with its clients, Diapharm defines project objectives and identifies the optimal regulatory pathway to achieve them.

        See Overview

      • Development and Licensing
        Development and Licensing

        Diapharm develops OTC medicinal products for the industry and arranges suitable existing marketing authorisations and licences.

      • Investigational Medicinal Products (IMPs) 
        Investigational Medicinal Products (IMPs) 

        During a clinical trial, investigational medicinal products (IMPs) are used and tested.

      • Quality Management (GxP)
        • GMP Consulting & Audits
          GMP Consulting & Audits

          Diapharm supports clients in the effective and efficient compliance with GMP guidelines.

        • Quality Management System
          Quality Management System

          Diapharm handles the implementation and maintenance of quality management systems based on GDP and GMP guidelines.

        • Risk Management & FMEA
          Risk Management & FMEA

          Pharmaceutical quality risk management should be appropriate in scope, form, and documentation to the level of risk.

        • Manufacturing and Import Authorisation
          Manufacturing and Import Authorisation

          Pharmaceutical distributors or marketing authorisation holders without a manufacturing authorisation require a wholesale distribution authorisation for their activities.

        • API Audits
          API Audits
        Quality Management (GxP)

        Diapharm is a consulting company for pharmaceutical quality management, quality control, and quality assurance.

        See Overview

      • Scientific Information
        • Information Officer
          Information Officer
        Scientific Information

        Labelling of packaging, the summary of product characteristics, instructions for use, and promotional materials must comply with legal requirements and the marketing authorisation dossier.

      • Pharmacovigilance
        • Pharmacovigilance System
          Pharmacovigilance System

          The Qualified Person for Pharmacovigilance (QPPV) is responsible for ensuring that a pharmacovigilance system is in place within the company.

        • Qualified Person for Pharmacovigliance
          Qualified Person for Pharmacovigliance

          A Qualified Person for Pharmacovigilance (QPPV) must manage the pharmacovigilance system, assess medicinal product risks, and coordinate measures to ensure patient safety.

        • Risk Management Plan
          Risk Management Plan

          Pharmaceutical risk management should be appropriate in scope, form, and documentation relative to the level of risk.

        • PSURs
          PSURs

          For active substances requiring Periodic Safety Update Reports (PSURs), Diapharm prepares up-to-date, substance-specific PSURs.

        Pharmacovigilance

        In matters of drug safety, Diapharm is a reliable partner for the pharmaceutical industry.

        See Overview

      The Diapharm Philosophy to medicinal products

      Diapharm supports clients in the development and market introduction of medicinal products and ensures their quality and safety throughout the entire product life cycle.

      To Medicinal Products

    • Medical Devices
      • Taking Responsibility
        Taking Responsibility

        On behalf of our clients, Diapharm acts as the responsible manufacturer in accordance with the MDR and IVDR.

      • Clinical Evaluation
        Clinical Evaluation

        A clinical evaluation is mandatory for all medical devices in accordance with the Medical Devices Regulation (MDR).

      • Conformity Assessment
        Conformity Assessment

        At the end, the manufacturer’s declaration of conformity and the authorisation to place the product on the market with the CE marking are issued.

      • Maintenance
        Maintenance

        Diapharm ensures the monitoring and maintenance of conformity for medical devices and in vitro diagnostics throughout the product life cycle.

      • Combination Products
        Combination Products

        For medicinal products, Directive 2001/83/EC and Regulation 726/2004 apply; for medical devices, Regulation 2017/745 (MDR) applies.

      • HÄLSA Pharma GmbH
        HÄLSA Pharma GmbH
      The Diapharm Philosophy to medical products

      As the legal manufacturer, Diapharm assumes all regulatory responsibilities and brings medical devices to market quickly and efficiently.

      To Medical Devices

    • Food Supplements
      • Borderline Issues
        Borderline Issues

        Diapharm understands the requirements for food supplements, balanced diets, medicinal products, medical devices, and cosmetics, and develops strategies accordingly.

      • Portfolio Strategy
        Portfolio Strategy

        Diapharm analyses existing product portfolios of food supplement manufacturers and provides guidance for further development.

      • Verification of Marketability
        Verification of Marketability

        Whether a food product — a food supplement or a specialty food — is marketable involves many aspects.

      • Product Labeling
        Product Labeling

        Diapharm supports complete and accurate labelling and helps to prevent non-compliance issues.

      • Health Claims
        Health Claims

        Making a health-related claim for a food product is not optional; it is subject to strict regulations.

      The Diapharm Philosophy to food supplements

      Diapharm advises manufacturers of food supplements, foods for special medical purposes (FSMP), and specialty foods.

      To Food Supplements

    • Cosmetics
      • Labeling
        Labeling

        In the labelling of cosmetic products, a distinction is made between mandatory labelling and voluntary information.

      • Notification
        Notification

        Cosmetic products must be notified before being placed on the market, as required by the EU cosmetics regulation.

      • Product Information File
        Product Information File

        When a cosmetic product is placed on the market, the responsible person is obliged to maintain a product information file.

      The Diapharm Philosophy to cosmetics

      Diapharm advises and supports providers of medical skincare products in portfolio analysis, as well as in the development, evaluation, and regulatory implementation of their products.

      To Cosmetics

    Product Areas

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    • About Diapharm
      • People
        People

        More than 100 specialists are committed to our clients’ projects, think strategically, and ensure the smooth execution of all tasks.

      • Company History
        Company History
      About Diapharm
      Im Austausch

      Learn more about Diapharm.

      Diapharm supports the pharma and life sciences industry as a consulting firm – creating market access and value.
    • Downloads
      Downloads

      General information, brochures, certificates, or presentations. We also make all current materials available for download.

    • Contact
      Contact
    Company
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    To the Blog

    News, insights, surprises: Stay informed about all product areas.

    See Overview

    A new chapter for CTD

    A new chapter for CTD: Implications for the Industry

    With the CTD structure undergoing its largest update in 20 years, Diapharm examines the impact on future pharmaceutica...
    Graphic featuring medicines, test strips and a syringe on a blue background, with text about the EU Wastewater Directive and the Diapharm logo.

    Caught between environmental protection and supply pressure: Why the EU Urban Waste Water Treatment Directive is becoming a stress test for pharmaceutical companies

    The EU Urban Waste Water Directive (UWWTD) is sparking significant debate across the pharmaceutical industry.
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  1. Homepage
  2. Terms and conditions

Terms and conditions

You can download our terms and conditions of delivery and service (T&C) here:

Diapharm-ALB-deutsch-englisch.pdf

(237.41 KB)

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  1. Homepage
  2. Terms and conditions

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Diapharm GmbH & Co. KG

Am Mittelhafen 56
48155 Münster
Germany
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Phone: +49 251 60935-0
Fax: +49 251 60935-520
Email: info@diapharm.de

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