Quality Management

If you manufacture pharmaceuticals in the Emerging markets, Galenisys can help you meet WHO, European and American regulatory requirements. This is a big step towards getting your products into the world’s most profitable markets.

Galenisys can help you put in place top class quality management in your company to improve the effectiveness of:

• The Quality Organisation
• The Quality Systems
• The Regulatory Management

Galenisys can also help you to resolve technical issues at your factory.

Quality organisations

Our experience working with pharmaceuticals companies in Emerging Markets helps us create and implement the right organisational structure for your company. We can improve the effectiveness of your Quality Units by:

• Offering comprehensive training to the staff (please refer to the section ”training”)
• Helping you to recruit quality experts
• Providing an efficient organisational structure that will allow your company to maintain quality control and reduce costs
• Compiling up-to-date procedures and documentation. We can provide a complete set of reference documentation (English or French) tailored to your needs so you can continue operating to the highest level after our work is done.

Quality Systems

Our extensive experience working with both manufacturers throughout the world and regulators ensures that your quality system will meet the required standards (WHO or EMA or FDA).
Our consultants are up to date with the latest regulatory requirements. This helps us create and implement expert Quality Control and Quality Assurance procedures.

What Galenisys can do:

• Inspect your facility and conduct a full evaluation of your requirements
• Create a set of objectives for your quality systems and design a system that will meet them
• Help you to put in place the right structure to oversee and ensure quality at every stage of your processes

We will give your company everything that is needed to maintain your QC and QA to the targeted standards.

• A complete set of documentation ( English or French) tailored to your company, facility, manufacturing processes:
  • Detailed overview of your quality system
  • How to implement the quality system
  • Procedures for the management of the Quality system
  • How to review and approve the quality system
• A communication plan tailored to your company
• Training (English or French ) for the staff to help them understand the needs and uses of the different components of the system.

When this is done, Galenisys can help you design and execute the plan to implement the system.

Galenisys can also run a test to evaluate the effectiveness of the system in compliance with the targeted standard.

Regulatory management

Galenisys can help you ensure that your quality systems meet the regulatory compliance standards of WHO and of the leading agencies in Europe and the USA.

Galenisys has the experience you need to ensure your company meets the regulatory standards that you target.

Galenisys regulatory consultation services offer:

• A comprehensive compliance audit (please refer to the section “audits”). Our auditors will perform a Quality and Compliance risk assessment. If your company is trying to introduce its’ products into new markets, Galenisys can provide a quality system audit tailored to that markets regulatory requirements
• A way to improve your existing quality system. Galenisys can help you to improve your existing system and implement new quality organisations. Our targets are:
  • Be more effective and efficient
  • Simplify structures (organisational and reporting)
  • Promote team building
  • Improve managerial effectiveness
• A pre-inspection audit. If you want to fully prepare your facility for a regulatory inspection, Galenisys can conduct a pre-inspection audit (please refer to the section “audits”), to give you peace of mind and train your staff on how to handle the inspection process.

Troubleshooting quality issues

If you need to resolve technical issues at your facility, Galenisys can provide up-to-date knowledge and engineering expertise in the following areas:

Technical systems

• Water and utility systems
• HVAC and AHU’s
• Facilities
• Equipments
• QC laboratories
• Analytical methods
• Data management

Product contamination

• Sterility assurance
• Product contamination
• Product inspection

And Galenisys can help you in the management of the OOS (Out of Specification) and in the investigations in cases of non-conformity.