Galenisys Pharmaceutical Consultants - Pharma Consulting

“The expert in asepsis and sterility assurance“

PAT-EXPERTS Platform

The pharmaceutical industry is going through a period of intense transformation. There is a growing trend to use Artificial Intelligence (AI) and Process Analytical Technologies (PAT) in drugs manufacturing, with a particular focus on accelerating continuous manufacturing processes.

With this in mind, we wanted to be able to respond to our customers by providing them with a range of services and global support tailored to their needs.

With the launch of the PAT-EXPERTS platform, we are creating the first complementary, innovative and operational Competence Centre for R & D, Industrialisation and pharmaceutical and chemical Manufacturing.

It combines the skills of Inhalexpert, QbD Development Expert, Nir-Industry PAT specialist and Galenisys Pharmaceutical Consultants, leader in EMA and FDA requirements and in Qualification and Validation.

This synergy of services will combine the pragmatic approach of "Quality by Design", to define critical sources of process variability, with PAT (including NIR & RAMAN spectroscopy), to monitor, manage and improve processes to ensure that finished products are manufactured with the desired quality.

In the same way, we will assist you for validation of analytical methods involved in Quality by Design and PAT.
This will take into account the specific requirements of the FDA and EMA for the registration of analytical methods, modification of analytical methods, including the use of spectroscopic technologies especially in NIR.

Operational use of our services will ensure that manufacturing processes and finished products can be successfully managed, with an increased level of product and process knowledge, improved control, consistent and appropriate final product quality that goes hand-in-hand with a reduction in the cost of non-quality.

The added value of our "PAT-Experts" platform is as follows:

  • Implementation of a "Quality by Design" approach for the development and control of processes, from R&D to routine operations
  • Implementation of effective process monitoring via PAT systems using NIR technology tools
  • Assisted control methods and modifications to comply with EMA and FDA requirements

 

Core expertise

Aseptic Sterility Assurance

We have experts who are recognised throughout the industry and who have worked at both shop floor and strategic levels to ensure that sterile product quality is assured....

Qualification and Validation

If your infrastructure doesn’t meet regulatory standards, or isn’t robustly validated at each stage, compliance will become more difficult – and take longer...

Quality Systems

If you need world-class quality systems in place at your facility, Galenisys can help you design and implement robust quality systems that meet the latest US and EU standards...

Regulatory Compliance

If you want to make certain your facilities and procedures are compliant with regulations, ask Galenisys to perform a compliance audit...

Fields of specialisation

Capital Investement Projects

Operating in the Emerging Markets, you may soon need to increase your production capacity, enlarge your facility or plan a new green field site construction...

Pharmaceutical Consultants

Galenisys is a top-ranking pharmaceutical consultancy with extensive experience working with blue chip pharmaceutical manufacturers in North America and Europe...

Emerging Markets

Galenisys Consultants have practical experience in Emerging Markets. They have held positions in Industrial Operations and management of quality structures....

Business Excellence

Galenisys Business Performance brings you new insights and ways of thinking about the healthcare industry that improves the way your company works...

Galenisys Pharmaceutical Consultants - Pharma Consulting