Our company's mission is to globally offer validation service solutions for companies in the Life Sciences sector, maintaining high quality and recommending innovative proposals.


Understanding the various levels at which businesses operate raises questions about the qualification and validation processes required for regulatory compliance. Hence, we provide a completely free and exclusive consultancy to prepare your business* for market entry in the Life Sciences sector.

+190

Companies served

+1000

Trained professionals

+1000

Projects executed

+6

Innovation and quality awards

+15

Years in the Life Sciences market

Our solutions consider your specific needs and what's necessary to ensure compliance. Feel free to share your challenges, allowing us to connect you with the most suitable professional for assistance.

To better assist you, we'd like to understand your current position in the regulatory process. Are any of the listed topics presenting challenges for ensuring regulatory compliance and commercialization in the Life Sciences industry?

    At present, I have a limited budget to address the requirements of validation and qualification.I lack sufficient staff to handle the validation and/or qualification projects.I lack a team that can carry out the validation and/or qualification projects.My team needs to enhance their knowledge of validation.I have urgent validation and/or qualification projects that need to be completed within a short timeframe.Validation projects are highly time-consuming and demand greater agility.At present, the paperless software or electronic management platform I use for my validation and/or qualification projects does not meet my requirements.Other:

    Our consultants

    Silvia M

    Silvia Martins is an electrical engineer with two decades of expertise assisting Biopharmaceuticals and Medical Devices companies. She has served many clients in several countries in validation, IT, and OT infrastructure qualification and in Data Integrity and Data Governance. As the CEO and co-founder of FIVE Validation, a firm devoted to optimizing compliance procedures, her dedication is to expedite and simplify compliance for customers. Silvia is also the idealizer behind the digital validation platform known as GO!FIVE®.

    Lilian R

    Lílian has nearly 10 years of technical and business experience in the food industry, specializing in corporate quality and quality control. Additionally, she has experience in the health/pharmaceutical sectors. As a paperless validation enthusiast, Lílian is passionate about bringing efficiency and innovation to Life Science companies.

    Her expertise lies in validation and qualification projects, including VLMS, ERPs, EQMS, automation (PW), and IT Infrastructure Qualification.

    Laura M

    Biotechnological Engineer and master’s in microbiology with over 10 years of experience in Life Sciences, specializing in validation of cleaning, processes, and equipment qualification. Strong focus on Quality Control within the personal care, cosmetics, and sanitizing products industry. At FIVE Validation, her focus lies in validating computerized systems, equipment, and infrastructure qualification. Possesses extensive knowledge across various domains, including ERP systems, automation, pharmacovigilance, CDS systems, weighing systems, EQMS, embedded systems, and infrastructure qualification. Additionally, excels in project and team management, complemented by training in quality management, information security, and validation.

    Luana R

    Graduated in Chemical Engineering and Technology in Biomedical Systems, specializing in Project Management and holding an MBA in Integrated Management Systems. With 10 years of experience in analysis laboratories within the chemical industry, she specializes in Life Sciences.

    She has undertaken validation projects for diverse management and quality control systems in the pharmaceutical, medical, cosmetic, and veterinary sectors.

    Additionally, she possesses expertise in equipment qualification, infrastructure, and auditing.

    (*) Note: FIVE Validation reserves the right to decline consulting requests that are not aligned with the company's mission and vision.


    (*) Note: FIVE Validation reserves the right to connect you with the most suitable professional for assistance.