M ao Cubo – Regulatory Consulting provides a wide range of services to guarantee the quality and compliance of products. We develop Management and Quality Assurance Systems and monitor their performance.


Good manufacturing practices

Good Manufacturing Practices (GMP) is the part of Quality Assurance that ensures that medicines, medical devices and other products are produced and controlled consistently and in accordance with appropriate quality standards, as required by product specifications.

Because we know the regulatory requirements, we offer consultancy services in the area of ​​Quality Assurance, ensuring Compliance with GMP at each stage of the product life cycle, thus ensuring regulatory Compliance.

From early clinical stages through to product commercialization, in line with a Pharmaceutical Quality System (ICH Q10), we are your partner to ensure regulatory requirements are met, business goals are achieved and the health and safety of the patient are guaranteed and improved.

We have experience in various types of products and ensure the implementation and compliance with GMP, in accordance with current legislation, in the manufacture of:

  • Commercial medicines
  • Experimental medicines
  • Advanced therapy medicines
  • Combination products (medicines-medical devices)
  • Medical devices
  • Cosmetics
  • Medical cannabis



M ao Cubo – Regulatory Consulting supports the development and implementation of fully customized Quality Management Systems (QMS), based on ISO 9001 and ISO 13485 standards, including the preparation of procedure manuals.

With a view to Certification by Certification entities or Notified Bodies, we ensure that the Quality System achieves 3 objectives:

  • Lays the foundation for regulatory compliance and continuous improvement
  • Meets required regulatory requirements
  • It is appropriate for the product development phase, product type and scope of the organization


We are a reliable partner in the design, construction and management of QMS programs. Partnering constructively and collaboratively, we work together to understand, identify and evaluate systems for quality improvements.



M ao Cubo – Regulatory Consulting collaborates with companies by carrying out audits:

  • Internal audits to evaluate the performance of Quality Systems and promote continuous improvement
  • Supplier Qualification Audits