Launch of the innovative Services Platform, PAT-EXPERTS by Nir Industry

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 drug production, with particular acceleration of continuous manufacturing processes.

Based on this observation, Nir-Industry wanted to be able to respond to its customers by providing them with a comprehensive range of services and support, adapted to their needs.

With the launch of the PAT-EXPERTS platform, NIR creates the first complementary, innovative and operational Pole of skills at the service of R&D, Industrialization and Pharmaceutical and Chemical Productions.
It brings together the skills of Inhalexpert, QbD Development Expert, Nir-Industry specialist in PAT and Galenisys Pharmaceutical Consultants, leader in EMA and FDA requirements and in Qualification and Validation.
This service synergy will combine the pragmatic approach of “Quality by Design”, to define the critical sources of process variability, with PATs (in particular NIR & RAMAN spectroscopy), to monitor, manage and improve processes in order to guarantee that finished products are produced with the desired quality.

Likewise, Nir-Industry will assist you for the validation of the analytical methods involved in Quality by Design and PAT.
This will take into account the specific requirements of the FDA and the EMA regarding registration of analytical methods, modification of analytical methods, including the use of spectroscopic technologies, especially in NIR.
Operational use of Nir-Industry services will ensure that manufacturing processes and finished products can be managed successfully, with increased level of product and process knowledge, improved control, consistent and appropriate end product quality going hand in hand with a reduction in the cost of non-quality.

The added value of the “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 efficient process monitoring via PAT systems using the tools of
  NIR technology.
• Assistance on control methods and their modifications so that they are in conformity
  with EMA and FDA requirements.

For more information: Thomas Ricour, Manager of NIR-INDUSTRY
Email: ricour@nir-industry.com & contact@pat-experts.com