Haleus provides full regulatory services starting from the initial regulatory submission to marketing approval of the drug.
Haleus delivers a systematic and coherent approach, strategies and solutions to address regulatory challenges and queries and helps to achieve regulatory success.
Our experienced regulatory team had a wide range of capabilities for the submission in different regulatory like DCGI, FDA, EMA, NMPA etc. We can counsel for all type of technical operations and regulatory concerns which helps to stay away from any regulatory queries and to get approval/authorization within the timeframe.
Haleus has an excellent global regulatory capability which supports drug/clinical studies in every stage of clinical development and conduct. We had a thorough awareness on Global regulatory landscape; hence we totally understand the significance of providing sound regulatory strategies, services and technical support, and accordingly we provide the best feasible approaches for the clinical development and regulatory consultancy.
We apply our knowledge, experience, and insights to plan and execute best possible and feasible regulatory strategies to meet the regulatory requirement(s) for product development and clinical program.
Pre-Submission Preparation
IND & NDA Submission
Preparation of Regulatory Submission Dossier
GAP Analysis
Regulatory Consulting Services
Renew & Variation Application
Regulatory Strategy Development
Marketing application
Publication
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