AGILIX PHARMA CONSULTANTS Information

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. Agilix is built on the principle 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. 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. Our key services include: 1). Regulatory Services 2). Submission Preparation and Management Support (NDA, ANDA, NDS, ANDS and MAA for DP and DMF, ASMF, CEP for DS) 3). Life Cycle and Post Approval Management (major, moderate and minor post approval changes such as PAS/CBE-30/CBE-0, Type IA, Type IAIN, Type II variations, Post NOC changes submissions) (Annual Report, PADER, PSURS, Renewals) 4). Publishing (eCTD) Services 5). Facility Registration and Drug Listing Service 6). Integrated Services