Quality and Regulatory Management

Galenisys has the experience you need to ensure your quality systems meet regulatory compliance standards for leading agencies in the US and Europe – and to stay up to date with the latest legislation.

Our quality and regulatory consultation service offers:

Regulatory compliance checks

Galenisys consultants have extensive experience interacting with regulatory authorities in North America, Europe, Australia, Japan and Latin America – as well as special expertise gained in the USA, UK and France.

We can help you ensure your pharmaceutical company is ready for inspection by carrying out:

• Quality and compliance risk assessment
• Auditing and due diligence
• Product and facility registration

Our pharmaceutical consultants can also offer expert advice on international Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines, particularly with respect to the requirements of the FDA and EMA.

Improving existing quality systems

If you need to improve your existing quality systems and implement new quality organisations, Galenisys can perform a complete audit of your quality procedures and help you design and implement new ones where needed. Or, as we have done with larger organisations, instead of adding new procedures onto those already not followed, let us help you reengineer your quality systems from the ground up.

We can help you improve your existing quality systems to:

• Become more effective and efficient
• Simplify organisational and reporting structures
• Promote team building
• Improve managerial effectiveness with individual coaching

Learn more about how we can help you troubleshoot quality issues and improve your quality organisations.

Recruitment and training

To get the right quality systems in place and manage them effectively, you need talented, experienced professionals working for you.
Galenisys can help you find the right staff for your needs through our specialist recruitment service – or provide advanced-quality systems training to your existing employees.

We will help you define employee competencies, then train your staff to meet them – ensuring compliance with regulatory requirements at every stage.
Also, Galenisys can provide interim services for quality management positions.

Regulatory inspection preparation

If your facility is about to be inspected, don’t leave anything to chance. Ask Galenisys to help you be fully prepared for your inspection with pre-inspection auditing, training and management for your facility.
It could help ensure your products reach new and profitable markets.

Read more about training and auditing for compliance.