Overview

We are specialized in core Regulatory Consulting services and helping our clients with Filing of NDA / ANDAs in US and ASMFs in EU, Preparation of Generic Applications such as Paragraph II, III and IV, Post approval maintenance and submissions of PAS, CBE 30/CBE, Annual Reports in US and EU, Help with creation of customized FDA regulatory/development strategies Help with writing all submission documents, Design Final Printed Labeling and Container Lab, Help with responding to FDA questions during the approval process, Help with eCTD process and provide eCTD Preparation Services, Help with filling annual reports, adverse reactions, and ongoing CMC updates, Manage Good Manufacturing Practice (GMP) and clinical site audits. Also act as a U.S. Agent for non U.S. companies. Provide Pharmacovigilance Services including PADER and ICSR Submissions. Providing eSubmission Services such as: Preparing drug applications, amendments, annual reports, PADER submissions etc in eCTD format using industries leading eCTD preparation software, Validate the submissions using industries best validator which is used by FDA like agencies across the globe including EMEA, SPL Preparation for Establishment Registrations, Labeler Code Requests, Drug Listings, GDUFA Self ID Submissions etc., DUNS and establishment registration, self identification for all sites for drugs.