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The offer on this page is aimed exclusively at business customers.

Intermediates for Pharma

Midas is providing products and product related services in the fields of intermediates and starting materials for APIs. A global network and many years of experience enabled us to build up resilient supply chains which are in compliance with contemporary quality and environmental standards. Our products are supported by state-of-the-art regulatory documentation customized to your needs thus enabling a smooth approval by health authorities.

Working with Midas means:

  • More than 30 years of experience and networking in the pharma industry
  • Full coverage of regulatory aspects
  • Full QM support
  • Securing, upgrading & derisking critical supply chains
  • CLP & REACh compliance
  • Import & transportation of dangerous goods
  • Warehousing
  • Regulatory Strategy

    Strategy for defending and justifying complex starting materials towards Health Authorities

    • Impurities (M7, Q3A, nitrosamines) carry-over and risk-assessment
    • CMC documents compilation
    • Regulatory/QM support during filing/ lifecycle management
    • Fall-back plan


    Intermediates with ICH Q11 compliant documents

    Regulatory Complexity Intermediates for Biopharma

  • Smart Sourcing / Process Optimization
    • Internal database with over 10k starting materials and intermediates entries
    • Technology database supporting the identification of the right CDMO for your product

    Is your process still state of the art and/or competitive? We are experienced in offering a customized solution.

  • Securing & Upgrading of weak supply chains

    Challenges of old supply chains:

    • Documents & processes are no longer state of the art
    • Importance and interest of the concerned substance may change to the supplier 
    • Changes always trigger immense internal capacities

    Advantages of an up-to-date/improved supply chain:

    • De-risking shortage risks
    • Availability of upgraded documentation → possible extention to other markets & products

    We offer you a full-service package including technical, regulatory affairs and qualification support customized to your requirements sharing the load of your internal work.

Overview Intermediates for Pharma

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Your Contact

Dr.  Danielle Leone-Stumpf

Dr. Danielle Leone-Stumpf

International Division
Senior Director Intermediates for Pharma & BioPharma

Midas Pharma GmbH
Rheinstr. 49
55218 Ingelheim
Germany
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