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Quality & HSE

Fully committed to your satisfaction

Our commitment to quality take place at each level of our organization, from the development and deployment of robust quality systems that help ensure regulatory compliance and support audits. Our goal is to continually strive for Operational Excellence and to guarantee our customers’ products and data integrity

Our Quality and HSE Management Systems guarantee our customers high standards of quality, safety and performance.

Quality

 

Dedicated to ensuring your product quality through highly skilled employees and procedures, always in compliance with GMP requirements (France’s National Agency for the Safety of Medicines and Health Products - ANSM) and specific regulations:

 

  • ANVISA (Brazil)
  • PMDA (Japan)
  • Other local health authorities
  • Download Elaiapharm Manufacturing Authorization
  • Download Elaiapharm GMP certificate for Human Medicinal Products
  • Download Elaiapharm GMP certificate for Human Investigational Medicinal Products

    • Our quality policy and standard operating procedures (SOPs) ensure regulatory requirements adherence. Our Quality System follows current Good Manufacturing Practices (GMP) guidelines and complies with relevant governing bodies.

    HSE

    our standards of excellence

    Lundbeck is committed to protecting the environment and maintaining health and safety working environment. We are ISO 14001 and ISO 45001 certifications across all our activities.

     

  • Download Elaiapharm ISO 14001 and ISO 45001 certifications

    • Quality of Life at Work

    Aware of the major challenges it represents, Lundbeck CDMO (Elaiapharm site) is committed to pursuing its process of continuous improvement of the Quality of Life at Work by promoting dialogue and the involvement of all through, in particular, action plans relating to occupational health, professional equality, labor relations, skills and career paths, job content.

    more from lundbeck sustainability

    Through our sustainability strategy, we mitigate business risks, reduce negative impacts and address societal challenges where possible. We remain committed to UN Global Compact Principles and contribute to six of the 17 UN Sustainable Development Goals.

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    More from Lundbeck CDMO services

    Solid Dosage 

    Our production systems meet current safety, environmental and quality standards, with recognized procedural knowledge in the development and manufacturing of tablets and micro-tablets.

    Sterile

    We manage the development and manufacturing of injectables freeze-dried and liquid products in vials.

    Packaging

    We manage primary and secondary packaging services in blisters, bottles and kits.