agilix consultants
About Us
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.
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
-
Agility
-
Excellence
-
Client Centricity
-
Transparency
-
Teamwork
agilix consultants
Services
Regulatory Strategy and Insights
-
Strategic Regulatory Planning
-
Regulatory Intelligence
-
Global Regulatory Navigation
-
Regulatory Gap Analysis and Due Diligence
Submission Preparation and Management
-
Submission of Full Applications (NDA, ANDA, NDS, ANDS and MAA etc)
-
End-to-End Product Registration
-
Market Extension Dossiers
-
End-to-End DMF Registration (DMF, ASMF, CEP etc)
Life Cycle / Post Approval Management
-
Change Evaluation and Submission
(PAS/CBE-30/CBE-0/Post Approval Variations for EU/Post NOC change submissions for CA etc) -
Product Life Cycle Submissions
(Annual Reports/PADERs/ Product Renewals/PSURs etc)
Publishing (eCTD) Services
-
End to End eCTD Submissions
-
eCTD Life-Cycle Management
-
ESG Portal Document Transfer
-
Paper/NeeS to eCTD Conversion
-
Document Level Publishing
Facility Registrations and Drug Listing Services
-
Facility Registration
-
Drug Listing
-
Regulatory Compliance Management
-
Renewal and Maintenance
Integrated Services
-
Regulatory Project Management Support
-
Drug Development Regulatory Support
-
QMS & Audit Support
-
GxP Services