Pharmaceutical Compliance Services

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.

Quality Compliance Consulting

We’re here to help you to:

Sterilization Process Management & Control

Sterilization Process Management and 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:

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.

Microbiology Consultant

We're here to help you if:

Organization Capability

Quality Organization

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:

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.

Proactive Supplier Management

We’re here to help you to:

Validation Activities​

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:

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.

e-Validation Software
e-Validation Software

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.

human error prevention and reduction solutions

We’re here to help you to:

Do you have other specific needs?

 

Tell us what you are looking for. We'll put our team to work on your specific needs.