Pharmaceutical Compliance Services
What are your business challenges?
Our services focus on critical business needs as: performance improvement, capability development, and compliant growth.
Quality & Compliance
Link quality and business strategy
Our consultancy aims to optimize the efficiency and efficacy of your Quality Management System in compliance with applicable regulatory requirements and, most important, your business needs. We can support you in developing a strategy and action plan to address your processes, procedures, and talent capabilities.
We’re here to help you to:
- Develop a strategy and align your Quality Management System with your business goals.
- Identify opportunities and solutions to enhance the efficacy of your Quality Management System.
- Identify ideas and insights to enhance your quality & compliance performance and get more results.
- Identify opportunities and improve your readiness state for external audit.
Sterilization Process Management & Control
Ensure quality while improving operational efficiency.
We can help you address gaps or improvement needs for your products with bioburden testing, endotoxin testing, and environmental monitoring and documentation. Our expertise in sterilization management (Moist heat, Irradiation or Gas Sterilization, clean room requirements), Training, Sterilization validation, and documentation can help you to ensure a robust sterilization process that stand ready to help in the final stages of the product manufacturing.
We’re here to help you to:
- Identify opportunities and solutions to improve the results of your Sterilization process.
- Identify ideas and insights to enhance your products sterilization process, results and compliance to applicable requirements.
- Develop solutions to address gaps in your controlled manufacturing environment validation, monitoring, and documentation.
Microbiology
Ensure quality while improving operational efficiency.
We can support you to analyze your labs, process, practices to identify gaps or improvement opportunities in the laboratory, that means to have a traceable and accurate test result. Accordingly, any level of inaccuracy can result in FDS 483's and/or warning letters or worse, the products will not be safe for their intended use.
We're here to help you if:
- You are struggling with microbiology test execution, laboratory safety and biosafety procedures or achieving the desired results.
- You need some ideas and insights to microbiology tests, results and compliance to applicable requirements.
- You want to improve or address gaps in your microbiology tests, validation, monitoring, and documentation.
Organization Capability
Improve the value proposition of your Quality Organization
We can help you to deliver against the quality objectives, short-term and long-term business goals through our unique process. The organizational structure and capability assessment consider planned changes, compliance/performance, company strategy, and goals.
We’re here to help you to:
- Identify what quality organization you need to deliver your business goals.
- Identify opportunities to enhance the executing your QMS and deliver the expected results.
- Identify opportunities to enhance your quality organization capability and add more value to your business.
Proactive Supplier Management
We can help your suppliers meet business needs while being cost-effective.
Providing a customized solution to your purchasing control, including SQM process assessment, supports you to develop an action plan to mitigate risks, improve your system's efficiency, improve your supplier base capability in alignment with applicable regulatory requirements and industry best practices.
We’re here to help you to:
- Develop a strategy and align your Supplier Quality Management with your sourcing and business goals.
- Identify opportunities to manage the growing size and complexity of your supplier base.
- Identify opportunities and solutions to enhance the performance of your suppliers.
Validation Activities
Do you have more processes to manage with fewer resources?
Lower your burden and boost your operational efficiency.
We’re here to help you to:
- The appropriate paperless validation system to execute your validation activities and deliver the expected results.
- Smart and efficient solutions for your validation activities aligned with your business growth.
- Opportunities to enhance your validation activities performance and get more results.
e-Validation Software
GO!FIVE™ is a Paperless Validation Software, based in Cloud Computing, with unique features that will optimize time and reduce costs of validation activities. The e-Validation Software is compatible with mobile devices and can also be accessed by computer, with the most used browsers.
Solutions in Validation
• We provide a broad range of reliable and cost-effective services for your validation needs.
• The FIVE Validation services is a reliable and cost-effective solution to your needs in compliance with regulatory agencies such as FDA.
• We also can perform the validation activities remotely with our experienced professionals, our unique software platform (GO!FIVE™), and a completely paperless validation system.
Human Error Reduction
Are you tired of addressing the same human errors in your organization?
We can help you to free-up valuable resources, improve safety, quality, and business performance by reducing human errors. This action learning process will provide a systemic view of human errors, why they occur, their different types, contributing factors, how to investigate them, and guidance towards productive strategies and human error prevention and reduction solutions.
We’re here to help you to:
- Identify why and what human errors occur in your business.
- Identify an effective strategy and actions to reduce or prevent human errors.
- Develop and implement actions to eliminate or minimize the re-occurrence of human errors.
Do you have other specific needs?
Tell us what you are looking for. We'll put our team to work on your specific needs.
