• Select your website

BioPharmaceuticals

Process Engineering & Technology Transfer

Validation - Commissioning & Qualification

Quality Assurance Consulting

Quality Intelligence - A Roadmap to Quality Excellence

Regulatory Consulting

Operational Excellence

 

 

Process Engineering & Technology Transfer

Altran provides engineering support and project management across the overall manufacturing process including development, industrialization, manufacturing, maintenance and optimization to help our clients:

  • Adapt the manufacturing capacity to business needs
  • Comply with new regulatory requirements
  • Implement new technologies
  • Save costs

Altran has a broad experience in upstream, downstream and fill finish processes.  The industry is under constant pressure to reduce costs and to adapt to evolving market needs, regulations and guidelines.  Companies are eager to implement a holistic approach to manage their investment projects in the most efficient way, without generating extra cost or overtime throughout the different project phases.

 

 

Validation - Commissioning & Qualification

Altran has over 20 years of experience helping our clients define the user requirements and functional specifications before starting qualification activities. Afterwards, Altran provides support during the entire qualification cycle from FAT over SAT to commissioning/verification and IQ/OQ/PQ activities to make sure that the equipment and facilities are fit for intended use.  This continuous support helps to ensure a safe and efficient start-up of new equipment and facilities, as well as changes to existing ones.

 

 

Quality Assurance Consulting

Altran believes that efficient compliance solutions require a balanced mix of strong knowledge management, smart risk management and the requisite expertise and competences.  Altran's dedicated Quality Assurance solution is designed to help our clients:

  • Remain up-to-date with regulations at all times
  • Have a compliant quality system adapted to company/site specifications
  • Be pragmatic and efficient
  • Increase compliance and performance
  • Reduce the cost of quality

Medical product development and manufacturing are tightly controlled activities subject to strict guidelines laid down by national and international regulatory agencies.

 

 

Quality Intelligence - A Roadmap to Quality Excellence

Tightening regulations and increasing business risk are the key challenges facing the Life Sciences Industry in the never ending task of securing product quality and patient safety. Our paramount solution to this very need is called Quality Intelligence (QI). QI is a new methodology and innovative approach. It is considered a major asset to our clients because it assesses and identifies areas of improvement within a company’s quality-system processes. In addition, QI offers a systematic approach with diagnostic solutions that can easily be customized to address specific challenges.

 

 

Regulatory Consulting

Altran's dedicated Regulatory Affairs solution is designed to help our clients:

  • Optimize regulatory affairs monitoring in order to comply with time-to-market requirements
  • Achieve regulatory compliance of products, as well as ensuring their access to and the maintenance of their position on the market
  • Establish "Regulatory Affairs" as a key element to success

Given the increasingly stringent regulatory constrains and the threat of potential lawsuits that companies could incur should they fail to respect quality, safety and efficiency requirements, sector players must secure their products and control their impact in order to obtain and maintain market access.

 

 

Operational Excellence

Altran's dedicated Operational Excellence approach is designed to help our clients transform their operations from a holistic point of view in order to:

  • Improve the performance of the manufacturing site
  • Enhance the supply chain performance
  • Improve the quality systems efficiency