Regulatory Compliance
Service Overview
We provide end-to-end regulatory compliance solutions to ensure your pharmaceutical products meet global standards. From DMF and dossier submissions to pharmacovigilance, batch release, and marketing authorization holding, our expert team streamlines approvals and maintains compliance across jurisdictions. With strategic scientific advice and multilingual translation support, we help you navigate complex regulations with confidence.
The following services are integral to the Market Access solution of Qgenyx
DMF Preparations/Submissions
Comprehensive Drug Master File preparation and submission services for regulatory compliance across global markets.
Dossier Preparations/Submissions
Expert dossier preparation and submission support for regulatory approvals in various jurisdictions.
Pharmacovigilance
Complete pharmacovigilance services including safety monitoring, reporting, and risk management.
MA Holding
Marketing Authorization holding services to maintain compliance and regulatory status.
EU Importation & Batch Control / Batch Release
EU importation support with comprehensive batch control and release procedures.
Scientific Advice
Strategic scientific advice and regulatory guidance for product development and approval pathways.
Translation Services
Professional translation services for regulatory documents and submissions in multiple languages.
Why Choose Us
- Extensive experience in global regulatory compliance across multiple jurisdictions
- Expert team with deep knowledge of pharmaceutical regulations and requirements
- Proven track record of successful submissions and approvals
- Comprehensive support from initial planning to final approval
Key Benefits
- Global regulatory expertise across multiple jurisdictions
- End-to-end compliance support from planning to approval
- Comprehensive documentation and submission services
- Risk mitigation and regulatory strategy
Ready to Get Started?
Contact our expert team to discuss your regulatory compliance requirements.
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