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Regulatory Compliance

With ever-changing global regulatory requirements for the Life Sciences industries work with a partner that can get your products to market safely and in a timely manner, while adhering to the relevant regulatory requirements.

Do you really want to reduce your costs?

  • To reduce costs, a real understanding of regulatory requirements is needed – specialist engineers to support you that are dedicated to following global regulations.
  • Standardization reduces customization. Built-in features to meet regulations such as FDA 21 CFR Part 11, PAT can save you time and money. Work with Life Sciences consultants that work closely with product development teams to continuously follow and implement the latest regulatory requirements in products and solutions.
  • Use proven, standard validation templates based on ISPE GAMP5 guidelines.

 

联络专员

It is important that you have confidence in a partner for your validation needs …

  • Successful completion of validated systems around the world.
  • Involvement in major Life Sciences professional organizations e.g. ISPE, GAMP, ISA.
  • Experience significant reductions in validation costs by engaging Eurotherm at the beginning of a project and resolving mulitple issues before manufacturing begins.
  • Work with a company that has had successful audits by major Pharmaceutical and Biotech companies.
  • Work with products that are manufactured and tested to ISO9001.

Environmental Monitoring Systems

Digitalize environmental monitoring aiding Life Sciences regulatory compliance.

Discover our EMS

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