Regulatory Cycle Management
Regulatory affairs for the industries we serve are cyclic in nature, where each step is dependent on the previous, as well as the next. We at Globi-Corp, provide extensive support, that allows our clients to move forward in the regulatory cycle through quick processing time, effective solutions, and a pragmatic attitude that keeps the cycle flowing, uninterrupted.
We specialize in gap analyses of product documentation against the desired registrable market and regulations, with a focus on identifying and curing defects, thereby avoiding ‘Refuse to Receive’ (RTR) remarks from relevant industry regulators.
Our expertise helps speed up registrations thereby maximizing market potential, without delays.
Our extensive knowledge base and practice experience, combine to simplify complex registration procedures and documentary requirements of global regulators at the product’s idea evaluation stage itself.
Our expertise allows clients to minimize technical flaws and delays, allowing them to focus on product development and launch.
Approvals & registration procedures get derailed when regulators raise queries on submitted dossiers. This often happens due to clients misunderstanding queries, providing improper replies or even just delays in providing simple accurate responses.
Our management and experience allows for timely responses, accurate rectifications as well as tracking original submissions against finally approved dossiers.
Approvals & Variations
While our experience and expertise may result in a high approval rate, our clients often face difficult challenges when it comes to post-approval variations in registered dossiers, their classification and resulting impact.
Our experts’ cumulative experience ensure that registration dossiers as well as variations in registered dossiers are optimized to qualify for smooth and timely approvals.
Our mantra for regulatory affairs, i.e. Identify, Simplify, Rectify and Qualify has consistently resulted in a high degree of satisfaction with our existing client base, who continue to place their trust in us.
Our comprehensive knowledge base & experience, expert management, effective solutions and high approval rate is why clients trust Globi-Corp with their hard earned reputations.