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Quality Management System

A Quality Management System ensures consistent quality, compliance, and continuous improvement through standardized processes and procedures.
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Quality Management System

Quality Management System

MRB Next GenTech’s Quality Management System ensures that the highest standards of quality and safety are maintained throughout the development and manufacturing of regenerative therapies. Our approach is built on trust and integrity, ensuring compliance with international regulations and providing robust support for every client project.

Benefits:

  • Regulatory Compliance:
                                     Our quality management system is fully compliant with international regulations, including FDA, EMA, and other global standards.
  • Continuous Improvement:
                                     We are committed to continuous improvement, ensuring that our quality systems evolve with the latest industry standards.
  • Risk Mitigation:
                                   Through proactive risk management, we minimize the potential for issues that could impact product quality or patient safety.
Quality Management System image

Key Services:

  1. Document Management: Comprehensive documentation management ensures that all records, from development to manufacturing, are maintained with precision and accuracy, facilitating smooth audits and inspections.

  2. Qualification and Validation: We provide thorough qualification and validation services for equipment, processes, and systems, ensuring that every aspect of production meets the required standards.

  3. Material and Vendor Qualifications: Rigorous qualification processes for raw materials and vendors guarantee that all inputs meet the stringent requirements necessary for regenerative medicine products.

  4. Quality Risk Management: Our risk-based approach identifies potential issues early, allowing us to mitigate risks before they impact product quality or safety.

  5. Regulatory Agency Collaboration: We maintain proactive communication with regulatory agencies, ensuring that our processes align with the latest guidelines and that we are prepared for inspections and audits.

  6. Audits and Inspections: Regular internal and external audits ensure compliance with Good Manufacturing Practices (GMP) and other relevant standards. We support our clients through every stage of the inspection process.

  7. Personnel Training and Compliance Management: Continuous training programs keep our staff updated on the latest quality standards and regulatory requirements, ensuring that everyone involved in the production process maintains the highest level of competency.

  8. Compliance Status Management: We monitor and manage the compliance status of all aspects of our operations, ensuring that any non-conformances are addressed promptly and effectively.

Who Should Consider This Service:

  • Biotech and Pharmaceutical Companies: Companies in need of rigorous quality management systems to ensure the success of their regenerative medicine products.
  • Clinical Researchers: Researchers who require robust quality controls to support clinical trials and regulatory submissions.
  • Regulatory Authorities: Agencies looking for reliable partners to ensure that regenerative therapies meet the highest standards of quality and safety.

Frequently Asked Questions (FAQs)

What are the key components of your Quality Management System?
Our system includes document management, risk management, qualification, validation, and more.
What type of audits do you perform?
We conduct both internal and external audits, ensuring that all processes meet GMP and other relevant standards.
Do you offer training for personnel?
Yes, we provide ongoing training to ensure all staff are up-to-date with the latest quality standards.