International Regulatory Services

From initiation to end, CoreLEX ensures complete compliance, making your route easier in various markets for your products.

CoreLEX is a leading Global Regulatory Services provider for pharmaceuticals, Medical Devices, Foods and Cosmetics.

With primary operating region in India, Sri Lanka, Nepal and offices around the world, CoreLEX has a large global presence to meet the requirements of clients.

We provide complete dossier services for regulated market as well as rest of world (ROW) market.

CoreLEX Group’s regulatory affairs services:

We have the technical ability and resources to be your universal partner in regulatory compliance management, easily transforming all the regulatory uncertainty into clarity and control.

• Our global regulatory is down with due diligence, conducted by our expert teams with local expertise, who can evaluate your current regulatory standing across every market and solve the country-specific challenges which they find.
• We expertly classify, register, document, reviewand submit all your regulatory obligations, leaving you free to focus on the business end.

CoreLEX provide dossier preparation and compilation in Common Technical Dossier (CTD) format for regulated as well as rest of world (ROW) market and Conversion to eCTD for US FDA, Canada and European counties etc.,

Common Technical Document (Product Dossier) is an integral Part of any registration application for Marketing Authorization.

• Module 1 – Administrative Information

• Module 2 - CT Overview

• Module 3 – Drug & Product Part /CMC

• Module 4 – Non Clinical

• Module 5 – Clinical

Preparation of DMF (Drug Master File):

We have associated with FDA/NABL Certified well established labs to carry out analytical testing of your products.

We also perform the following studies, in co-operations to DMF preparation:

• Structural Elucidation Studies
• Analytical Report (COA)
• Analytical Method Validation
• Process Validation
• Stability data studies
• Determination & Validation of Potential Impurities & Solvent Impuritie       (All the data supported by necessary Chromatograms & Spectrums)