Services
Product Registration & Approval Requirements
Clear identification of required documents and approval pathways to support informed regulatory decisions.
Regulatory Dossier Preparation
Preparation and compilation of regulatory dossiers in line with local and international authority requirements.
Implementation of Regulatory Requirements
Implementation of applicable regulatory guidelines across development and post-approval stages.
Dossier & Data Compliance Review
Detailed review of regulatory dossiers and data packages to ensure completeness and compliance.
Regulatory Query Handling
Professional handling and response to regulatory authority questions and deficiency letters.
Resolution of Complex Regulatory Issues
Strategic support for resolving challenging regulatory and compliance-related issues.
GMP Documentation Review
Review of GMP documents and identification of potential products for regulatory submissions.
Regulatory Strategy & Project Management
Development of regulatory strategies with end-to-end project management support.
Method Validation & DMF Filing
Review and filing of analytical method validations and DMFs as per regulatory requirements.
Audit of Sites & CROs
Conduct of regulatory and GMP audits for manufacturing sites and Contract Research Organizations.