Smart Engineering Solutions
Pharmaceutical & Biopharmaceutical Industries
Maximizing your product’s lifecycle performance is key to extract as much value as you can from the investment made. This calls for a holistic approach that allows you to manage your products and related information across the enterprise.
Improved time-to-market, better product quality, regulatory compliance, cost reduction, less waste, and cycle time reduction. Quality by Design supports it all. Having a solid Quality by Design framework supported by the latest technology will have a major impact in your business operations. Our decade of experience and proprietary state of the art software can help you.
Maximizing your product’s lifecycle performance is key to extract as much value as you can from the investment made. This calls for a holistic approach that allows you to manage your products and related information across the enterprise.
Maximizing your product’s lifecycle performance is key to extract as much value as you can from the investment made. This calls for a holistic approach that allows you to manage your products and related information across the enterprise.
Process Deviations are intricate. When your process is not yielding what you expected, when you have tried different ways to solve it and the process deviation remains, you probably need a different approach. We can help.
It's time to make your risk assessments easier, streamline your operations and improve your reporting. And most importantly, you will use your resources better. What are you waiting for?
Maximizing your product’s lifecycle performance is key to extract as much value as you can from the investment made. This calls for a holistic approach that allows you to manage your products and related information across the enterprise.
It's time to make your risk assessments easier, streamline your operations and improve your reporting. And most importantly, you will use your resources better.
Nitrosamines in batches of products containing Sartan derivative, Ranitidine or Metformin are a cause of concern. Regulatory agencies expect you to submit a Risk Evaluation Report as well as an action plan to deal with identified risks. To support you with this, 4TE delivers Quality Risk Management Optimisation built on top of our Consultancy services and QRM digital platforms.
The pharmacology of cannabis is complex due to specific risks related to the wide range of naturally occurring compounds. As the industry evolves, it is expected that GMP compliance and certification will become the standard similarly to the food and pharmaceutical sectors. However, having a complete understanding of existing regulations (regional and global) and business risks involved in obtaining GMP certification can be challenging. To help you with this, 4TE provides our expertise in Quality Risk Management (QRM) built on top of our Consultancy services and QRM digital platforms.
Cell and Gene Therapies (CGT) have advanced significantly in recent years, with more companies investing in this type of products. As with all product development processes, risk management has an important role on demonstrating patient risk mitigation. To help you with that, 4TE delivers specialized Quality Risk Management (QRM) for CGT built on top of our consultancy services and QRM digital platforms.
Easy Risk Assessments, Streamlined Operations and improved reporting. And most importantly, you will use your resources better.
Sometimes you need a solution different from the standard market offer. We have experience designing, building and implementing custom-made software for leading Pharmaceutical, Biotech and Medical Firms. We’ll help transform your business.
The manual Continued Process Verification (CPV) implementation is a slow and resource-consuming process. Implementing a digital CPV can yield benefits in automatic data capture, organisation, visualisation and reporting, substantially improving your Quality Assurance and reducing massively the time and resources necessary for it to happen. 4TE can support the digitalisation of your Continued Process Verification and with it help you reduce your costs and enable a real-time verification that your process is within a state of control.
+255
Projects commissioned
since 2004
44
% of top 50 Pharma Companies
our partners
97
% of the clients
stay with us
36
% of yearly avg. growth
# of clients
Born in Lisbon, but reaching out for the world. 4TE was created to deliver engineering solutions to organisations in the pharmaceutical and biopharmaceutical field.
For the last two decades we have become a reference in pharmaceutical plant engineering, production scale-up, digital transformation and transition to the 4.0 Industry.
Our solutions are built on top of our experienced Consultancy, our Risk Management Platform iRISK™ and our Process Lifecycle Management Platform iSEE Platform™
awarded for:
Top Risk Management
Solution Providers
2020
awarded for:
Top 20
Risk Management Solutions
2017
awarded for:
TOP 5%
National SME's
2020
awarded for:
SME
Excellence
2019
awarded for:
TOP 10%
National SME's
2019
awarded for:
Most Reliable
Risk & Compliance Tech Provider
2019
awarded for:
SGS
ISO9001:2015
2014-2020
awarded for:
ASSOFT
certification
2017-2019
awarded for:
SME
Leader
2018-2019
When we decided to go with iRISK from 4TE, we warned them that this would be a challenge for them as we wanted to have the roll-out concluded within less than 6 months. But the support we received from all of their team members, their willingness to accommodate our requests and timelines, and their expertise in resolving all the issues that came up during the project was amazing.
“We have undertaken the challenge to roll out a harmonised approach to Quality Risk Management throughout development at all of our sites as part of our QbD driven development approach. Eight legacy sites in six countries using the same software, the same templates, the same wording, and agreeing on harmonised workflows.
When we decided to go with iRISK™ from 4TE for this project we warned the team of 4TE that this will be a real challenge for them as we wanted to conclude the roll out within less than 6 months and to have the software fully operational at all sites by beginning of 2021. But the support we got from all of the team members from 4TE, their willingness to accommodate our requests and timelines, and their expertise in resolving all issues that came up during definition and implementation of the requirements was really amazing.
And we therefore managed to achieve our objectives despite all the obstacles caused by Covid-19 preventing us to meet face to face. The team is extremely responsive, knowledgeable and willing to go the extra mile at all times. Thank you, it’s a pleasure to work with you and I look forward to continue doing so.”
Welcome to our Product Lifecycle Wall!
Here you will be able to see how can we bring value to you in each step of your manufacturing process and respective activities.
Feel free to explore it, as one of our digital or technical solutions fits what you need!
And if there's any way we can help you, let us know! 👇
Research & Development
Process Qualification & Validation
Commercial Operations
Discontinuation
Our Lifecycle Solutions
Part of new products, bioequivalents or biosimilar workflow
Research & Development
Process Validation & Qualification
Commercial Operations
Discontinuation
Product Discovery
QTPP (Quality Target Product Profile): Define Quality targets such as clinical relevance, efficacy, and safety.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
Perform Initial Risk assessment, to identify Critical Quality Attributes (CQA), Key Process Parameters (KPP), Critical Material Attributes (CMA), Key Performance Indicators (KPI) and Critical Process Parameters (CPP).
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
RISK REGISTER is an integrated and simple solution to QRM which allows for a streamlined environment where strategic risks are filled, managed and analyzed, while ensuring that risk mitigation actions are focused on the most significant threats to the business.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
iSEE Platform™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.
Define control strategy based on Design Space and Process Development
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
iSEE Platform™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
iSEE Platform™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.
RISK REGISTER is an integrated and simple solution to QRM which allows for a streamlined environment where strategic risks are filled, managed and analyzed, while ensuring that risk mitigation actions are focused on the most significant threats to the business.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
iSEE Platform™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
iSEE Platform™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.
RISK REGISTER is an integrated and simple solution to QRM which allows for a streamlined environment where strategic risks are filled, managed and analyzed, while ensuring that risk mitigation actions are focused on the most significant threats to the business.
Risk Assessment studies.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
iSEE Platform™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
iSEE Platform™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
RISK REGISTER is an integrated and simple solution to QRM which allows for a streamlined environment where strategic risks are filled, managed and analyzed, while ensuring that risk mitigation actions are focused on the most significant threats to the business.
iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.
iSEE Platform™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.