Quality and Regulatory Management
PHARMIER CONSULT ltd. 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
PHARMIER CONSULT ltd. 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, PHARMIER CONSULT ltd. 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
Recruitment and training
To get the right quality systems in place and manage them effectively, you need talented, experienced professionals working for you.
PHARMIER CONSULT ltd. 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, PHARMIER CONSULT ltd. 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 PHARMIER CONSULT ltd. 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.