GMP Industrial/Clinical Lab Set Up

GMP Industrial/Clinical Lab Set Up

Our consultants are familiar with the applicable quality standards and can help you design or adapt your quality and safety processes in order to minimize the risks involved in (bio) pharmaceutical production.

Streamline Your GMP Lab Setup for Cell & Gene Therapy, Vaccines & R&D (US, EU, WHO, China)

Launching a GMP-compliant lab can be a complex process. At Atlantis Biosciences, we simplify your journey with expert consulting to help you navigate the complexities of GMP compliance and establish a high-functioning industrial/clinical lab.

Our consultants are familiar with the applicable quality standards and can help you design or adapt your quality and safety processes in order to minimize the risks involved in (bio) pharmaceutical production.

Our Expertise Empowers You:

  • GMP Lab Design & Construction:

    • Experienced consultants ensure your lab adheres to strict GMP regulations (US, EU, WHO, China).
    • Expert design and construction create a functional, compliant space for your specific needs.
  • Seamless Project Management:

    • Expert project managers oversee all phases, ensuring timely completion within budget.
  • Comprehensive Validation Services:

    • We validate your lab and processes to guarantee compliance and product quality.
  • Full Cycle GMP Compliance Support:

    • Our services cover the entire GMP lifecycle:
      • Laboratory Design & Layout – Optimize your lab space for efficient workflow and compliance.
      • Project Management – Stay on track with expert project management ensuring timely completion.
      • Validation – Ensure all equipment, processes, and systems meet GMP requirements.
      • Cleanroom Cleaning & Decontamination – Maintain a sterile environment essential for GMP compliance.
      • Technology Transfer – Seamlessly integrate new technologies into your lab operations.
      • Process Development – Develop robust and scalable processes for your specific needs.
      • GMP Manufacturing – Implement best practices for cGMP-compliant manufacturing.
      • Risk Assessment – Proactively identify and mitigate potential risks.
      • GMP Audits & Inspections – Prepare confidently for regulatory inspections.
      • GMP Training – Equip your personnel with the necessary knowledge and skills for GMP compliance.

Achieve Success Faster:

Partner with Atlantis Biosciences and leverage our expertise to:

  • Minimize Risks: Our comprehensive approach mitigates risks associated with (bio)pharmaceutical production.
  • Expedite Lab Set-Up: Efficiently navigate the GMP compliance process, saving you valuable time.
  • Focus on Innovation: Free yourself from regulatory complexities and dedicate resources to research and development.

Contact Us Today:

Ready to establish a world-class, GMP-compliant lab? Contact Atlantis Biosciences at [email protected], let’s discuss your project and design your path to a successful, GMP-compliant lab.

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