Pharma Compliance.
Simplified.
QA/QC, Qualified Person services, GMP/GDP compliance, and regulatory support for Indian pharmaceutical companies entering Europe.
The Challenge
- ×EU regulatory requirements differ from Indian/WHO-GMP standards
- ×Legal requirement for EU-based Qualified Person to certify every batch
- ×Extensive documentation and audit trail obligations
- ×Finding reliable EU partners who understand Indian pharma
- ×Time zone challenges and communication barriers
The QualiFlow Solution
- ✓Clear gap analysis to identify exactly what you need for EU compliance
- ✓Access to our network of certified EU Qualified Persons
- ✓Digital document management with full regulatory audit trails
- ✓Ireland-based team with deep understanding of Indian pharma industry
- ✓Overlapping working hours with India for seamless collaboration
How It Works
Gap Assessment
We evaluate your current compliance status against EU GMP requirements and identify gaps.
Remediation Plan
We develop a prioritized action plan to address gaps and bring you to compliance.
QP Assignment
We connect you with a Qualified Person from our network to certify your batches.
EU Market Access
Your certified batches are released to the EU market with full regulatory compliance.
Qualified Person Services
Access to EU-based Qualified Persons for batch certification and market release of your medicinal products.
GMP/GDP Compliance
Comprehensive assessment and remediation support to bring your facilities up to EU GMP/GDP standards.
QA/QC Support
Quality assurance and control consulting to establish robust systems meeting EU requirements.
Regulatory Affairs
Expert guidance on EU regulatory submissions, variations, and ongoing compliance maintenance.
Digital Platform
Secure, 21 CFR Part 11 compliant document management for batch records and QP review.
Training Programs
EU GMP training for your quality and production teams to ensure sustained compliance.
Why Ireland?
Ireland is Europe's pharmaceutical hub, home to 9 of the top 10 global pharma companies. Our location provides unique advantages for Indian pharma companies.
- ✓Direct EU market access via HPRA
- ✓English-speaking EU member state
- ✓Strong pharmaceutical regulatory expertise
- ✓Favorable time zone for India collaboration
Meet the Team
Asish Saxena
23 years in pharmaceutical manufacturing. Expert in EU GMP compliance and batch certification.
Deepak Bhattacharya
14 years driving quality excellence. Specialist in quality management systems and regulatory compliance.
Sud Sunkaraneni
14 years building technology for regulated industries. Leading QualiFlow's digital platform.
Pharmaceutical QA/QC • Qualified Person Services • GMP/GDP Compliance • Regulatory Support
Dublin, Ireland • Serving Indian Pharmaceutical Companies