Reaching New Heights in Life Science Compliance
Just as the Andes Mountains stand as a testament to strength and resilience, Andes Biotech provides robust and unwavering support in navigating the complex regulatory landscape of the life sciences industry.
Introducing GMPhub: The Next-Gen eQMS Powered by AI
GMPhub is designed to bridge the gap between rigid, traditional quality software and real-world GxP operations by embedding over two decades of regulatory consulting into a modern, AI-driven platform. Its primary intention is to transform compliance from a slow, reactive administrative burden into a proactive, continuous quality advantage.
Primary Objectives & Intentions
Automate Administrative Friction: Eliminate repetitive documentation cycles by using an AI GxP agent to generate technical drafts for deviations, CAPAs, and investigations in minutes instead of days.
Maintain Continuous Inspection Readiness: Centralize document workflows, electronic signatures, and audit trails under strict 21 CFR Part 11 and Annex 11 compliance, ensuring your Quality Unit is perpetually prepared for FDA, EMA, or ISO audits.
Combine Software with Human Expertise: Deliver an eQMS configured specifically around your facility’s SOPs, backed by direct access to Andes Biotech’s senior regulatory consultants.
Ultimately, GMPhub exists to empower regulated industries to scale their operations with complete regulatory confidence, minimal operational friction, and uncompromising quality standards
About Us
Andes Biotech Life Science Consulting is a premier Australian/European agency dedicated to improving patient lives by accelerating the development and commercialization of innovative therapeutic goods.
Combining over two decades of regulatory expertise with GMPhub—our proprietary, AI-driven electronic Quality Management System (eQMS)—we bridge the gap between high-level regulatory strategy and modern digital execution for global markets.
Our supportive, open, and excellence-driven culture empowers life science companies to replace rigid, paper-heavy operations with streamlined GxP workflows. By pairing direct consultant advisory with GMPhub’s intelligent automation, we ensure your organization achieves seamless market access, reduced administrative burden, and perpetual audit readiness.
Our Core Services & Digital Solutions
GMPhub eQMS & Digital Quality Management: Streamlining GxP compliance with our proprietary AI-assisted eQMS. Automating deviation drafting, CAPA investigations, 21 CFR Part 11 / Annex 11 electronic records, and real-time risk tracking for regulated industries.
Quality & Regulatory Lifecycle Compliance: Safeguarding product quality from early-stage development through commercial manufacturing using expert oversight and automated compliance monitoring.
Regulatory Approvals & Market Access: Guiding complex therapeutic products through international regulatory pathways (FDA, EMA, TGA) with structured, audit-ready documentation.
Pharmacovigilance & Safety Systems: Establishing and maintaining robust safety monitoring systems to protect patients and ensure complete data integrity post-market.
Medical Device & Biotech Commercialization: Supporting end-to-end development, technical file compilation, certification, and eQMS alignment for medical devices and advanced therapeutics.
Our Team
Mario Ignacio Ami
CO-FOUNDER & COMPLIANCE HEAD
Compliance and Regulatory expert with over 20 years of international experience designing robust GxP quality systems and ensuring compliance for biotech and pharmaceutical leaders.
PABLO BALDINI
CO-FOUNDER & TECHNICAL HEAD
Pharmacist and software engineer bridging GxP domain knowledge with advanced software architecture to design and build intuitive, compliant digital solutions for regulated industries.
MELINA CHIARAMELLO
FINANCIAL & COMMERCIAL STRATEGY HEAD
Specialist in reporting automation, forecasting, and data analytics. Leveraging deep tech sector expertise to optimize commercial strategies and drive data-backed financial modeling.
DIPESH SHARMA
e-Systems associate
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.
FILIPE ALMEIDA
BUSINESS DEVELOPMENT & SAAS HEAD
Executive leader with over 30 years in the biotech sector. Specializes in SaaS sales management, strategic growth, and data-driven decision-making to scale global market presence.
claudio raimondi
GXP CONSULTANT
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.
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!
