Reaching New Heights in Life Science Compliance
About Us
Andes Biotech Life Science Consulting is a leading Australian/European agency dedicated to improving patient lives.
We collaborate with businesses to develop and commercialize innovative therapeutic goods for global markets. Our supportive and engaging workplace fosters a culture of excellence, openness, and a strong work ethic, enabling us to deliver high-quality services and timely access to life-changing products.
We have extensive experience working with a diverse range of products, including Listed and Registered Medicines, OTC products, Complementary medicines, Medical Devices, Food Products, and Cosmetics.
“With precision and passion, researchers ascend,
To unravel the mysteries, where science transcends.
The Andes, a catalyst, for knowledge and might,
A beacon of excellence, shining ever bright”
OUR VALUES
Our Team
Our team of consultants bring many years of combined experience in Regulatory Affairs, Compliance, Quality Assurance, Access, Research & Intelligence, working with regulatory bodies around the world such as the TGA, Medsafe, FDA, EU Competent Authorities and Notified Bodies, and various global Authorized Representatives with a proven track record of executing techniques in a timely and cost efficient manner.
Let our team of experts assist your organisation with bringing new products to the market, as well as provide specialised regulatory knowledge that will maintain your current product portfolio’s compliance to industry standards, and place the quality of your product where it needs to be. We offer a comprehensive range of services to support your organization navigate the complex landscape of life sciences.
Mario Ignacio Ami
Managing Director
Proven track record of successfully leading high-performing teams and driving regulatory excellence within top-tier pharmaceutical companies for over two decades. Deep understanding of global regulatory landscapes, complex quality systems, and risk management strategies.
Greeshma Kurella
Quality, Regulatory and Compliance Head
Deep expertise in developing and implementing robust quality systems, managing regulatory submissions, and leading health authority audits to drive operational excellence within the pharmaceutical industry.
CLAUDIO RAIMONDI
QMS SPECIALIST
+20 years of experience in developing and implementing robust QMS Systems, for Pharma and Medical Device companies. More than a decade acting as Quality delegate for big pharmas.
DIPESH SHARMA
e-Systems head
Highly skilled in strategic planning, technology implementation, and driving operational efficiency. Proven ability to build and maintain high-performing e-teams, ensuring seamless integration of technology.
Yuliia Shcherbakova
Business Development Manager
Results-driven with a proven track record of driving revenue growth and building strong client relationships. Passionate about delivering exceptional customer service and exceeding client expectations.
YUEN MELISSA
Pharmacovigilance Manager
Broad knowledge of global Pharmacovigilance regulations/guidelines and practices through the experiences on Global single PV database implementation, Global PV system development, and PV department transformations.
Holistic
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Transformational
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Holistic
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Holistic
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Andes Biotech Life Science
Andes Biotech Life Science Consulting experience is varied working with Listed and Registered Medicines, OTC products, Complementary medicines, Medical Devices, Food Products and Cosmetics.
Let our team of experts assist your organisation with bringing new products to the market, as well as provide specialised regulatory knowledge that will maintain your current product portfolio’s compliance to industry standards, and place the quality of your product where it needs to be.
We are committed to the success of your products and to help you develop and implement regulatory and quality solutions catered to your needs.
At Andes Biotech, we understand that our greatest asset is our team. We cultivate a supportive and empowering work environment where employees feel valued, motivated, and inspired to achieve their best.
Recognizing the evolving landscape of work, we have embraced a fully remote-first culture. This allows our team members to work from locations that best suit their needs, fostering a greater sense of work-life balance and flexibility. Our AI-powered tools and collaborative platforms provide the infrastructure for seamless communication and collaboration, ensuring that everyone can contribute effectively, regardless of their location.
We believe in a horizontal dynamic where all team members are valued equally and encouraged to share their ideas and expertise. By prioritizing employee well-being and leveraging cutting-edge technology, we create a thriving environment where innovation and collaboration flourish.
Unlike traditional consulting firms, we prioritize people over profits.
That’s why we offer a complimentary 45-minute consultation to understand your unique needs and tailor our services accordingly. Let’s work together to make a difference!
Our Client’s
