agilix consultants
ABOUT US
agilix consultants
Founding Agilix – A Journey of Agility and Excellence…
The story of Agilix begins with a vision – a vision to redefine the regulatory landscape by combining agility with excellence. In an industry where change is constant and complexity is the norm, a team of passionate experts has come together, driven by the desire to make a difference. They have recognized that businesses, large and small, are navigating increasingly challenging regulatory environments and needs more than just compliance; they need a partner who can adapt swiftly and effectively to evolving demands.
With this realization, Agilix is born. The founding team, each a seasoned professional in their field, brought together a wealth of experience across various industries. But it was their shared commitment to agility and excellence that set them apart. They knew that to truly support their clients, they have to be more than just consultants – they have to be innovators, problem-solvers, and trusted advisors.
From day one, Agilix is built on the principle of agility and excellence. The team understand that in a world where regulations are ever-changing, staying ahead of curve requires more than just knowledge; it demands flexibility, speed, and the ability to anticipate what’s next. Agilix’s approach is not just to respond to changes but to proactively guide clients through them, ensuring they not only meet regulatory requirements but also thrive in their respective industries.
Excellence is another cornerstone of Agilix. The founders are passionate about delivering the highest quality service, believing that true excellence comes from a combination of deep expertise, attention to detail, and an unwavering commitment to client success. They foster a culture where every team member is encouraged to pursue continuous learning, stay updated with the latest regulatory developments, and always strive for the best outcomes for their clients.
Whether navigating complex international regulations or adapting to new compliance standards, Agilix becomes a trusted partner known for delivering results with speed and precision. Thereby, Agilix acts as a bridge between industry and health agencies like USFDA, EMA, EDQM, Health Canada and other agencies.
Today, Agilix stands as a testament to what can be achieved when a team of passionate experts commits to a journey of agility and excellence. It’s a journey that continues, driven by the same values that guided its founding – an unwavering dedication to helping clients succeed in an ever-changing regulatory landscape.
agilix consultants
Our Vision
To be the trusted partner in navigating complex regulatory landscapes, empowering businesses to achieve compliance with confidence and integrity. We envision a future where our expertise and innovative solutions drive sustainable growth and success for our clients, fostering a safer and more transparent global marketplace.
agilix consultants
Our Mission
At Agilix, our mission is to provide expert regulatory guidance and tailored solutions that ensure our clients meet and exceed compliance standards. We are committed to delivering accurate, timely, and strategic advice that simplifies regulatory challenges, safeguards business integrity, and promotes long-term success. By fostering strong partnerships and leveraging deep industry knowledge, we empower our clients to navigate the complexities of regulation with confidence and agility.
agilix consultants
Our Values
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Agility
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Excellence
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Client Centricity
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Transparency
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Teamwork
agilix consultants
Why Agilix ?
The Synergy of Agility and Excellence
Together, agility and excellence create a powerful synergy that sets our consulting business apart. Agility ensures that we are responsive and adaptive, while excellence ensures that our solutions are always top-tier. This combination allows us to offer a consulting service that is both dynamic and reliable, capable of guiding our clients through even the most complex challenges with confidence and clarity.
Expertise with a Fresh Perspective
At Agilix, we combine deep regulatory knowledge with the agility and innovation of a startup. Our team of seasoned professionals brings years of experience in navigating complex regulatory landscapes across various industries, while our fresh approach ensures that we’re always looking for new, efficient ways to solve challenges.
Tailored Solutions, Not One-Size-Fits-All
We understand that every business is unique, and so are its regulatory needs. That’s why we don’t believe in off-the-shelf solutions. Instead, we work closely with you to develop customized strategies that align with your specific goals, industry requirements, and risk profile, ensuring that compliance becomes a strategic advantage.
Client-Centric Approach
As a startup, we prioritize building strong, collaborative relationships with our clients. Your success is our success, and we are committed to providing the highest level of service, with a focus on clear communication, transparency, and delivering results that matter.
OUr Team
Umesh Dobariya
Founder and CEO
Umesh Dobariya, a visionary Founder and CEO of Agilix, brings over 15 years of extensive experience in drug regulatory affairs, has worked with leading multinational pharmaceutical as well as consulting companies. Throughout his career, he has gained significant expertise in Regulations and Compliances. His industrial tenure equipped him with the skills to navigate complex regulatory landscapes, ensuring that products meet stringent standards. During his consulting tenure, he has handled various projects of clients across the globe, like USA, Canada, EU and Japan, successfully addressing their regulatory and compliance needs.
His involvement in numerous operational and management roles, has been instrumental in helping clients to achieve their regulatory goals. His commitment to excellence and deep understanding of global regulatory frameworks makes him a trusted leader.
Himani Patel
Co-founder and COO
With over 15 years of experience in drug development and post-marketing, she brings a wealth of expertise across all phases of the drug development process. She excels in developing global CMC regulatory strategies with a focus on innovation, ensuring that business advantages are maximized while maintaining regulatory compliance.
Her hands-on experience includes navigating regulatory submissions for ANDAs, NDAs, ANDSs, and MAAs, and she is adept at managing queries, handling post-approval submissions (including variations, annual reports, PADER, and product renewals), and preparing eCTD submissions for multiple dosage forms.
She has extensive experience in controlled correspondence submissions, facilities registration (FEI and DUNS numbers), labeler code application (NDC), SPL preparation, and establishment registrations and renewals. Additionally, she is skilled in conducting comprehensive regulatory due diligence for prospective and incoming acquisitions, ensuring a thorough assessment of regulatory risks and opportunities.