Quality & Regulatory
Delivering pharmaceutical quality excellence, regulatory compliance, and ISO-certified manufacturing standards to ensure customer satisfaction, patient safety, and global healthcare trust.
Certifications & Achievements
Recognized by international regulatory authorities for pharmaceutical manufacturing, quality control, regulatory compliance, and global healthcare standards.
WHO-GMP Certified
World Health Organization Good Manufacturing Practice compliance for pharmaceutical quality and safety
Certified Since 2010
ISO 9001:2015
International Quality Management System certification for process control and continuous improvement
Certified Since 2012
GLP Compliant
Good Laboratory Practice standards ensuring accurate pharmaceutical testing and quality assurance
Certified Since 2015
FSSAI Approved
Food Safety and Standards Authority of India certification for regulatory and product safety compliance
Approved Since 2018
International Approval
Approved by leading foreign drug regulatory agencies ensuring adherence to global pharmaceutical safety and quality requirements.
Globally Compliant
Schedule M
Compliance with Revised Schedule M (2025) guidelines ensuring upgraded GMP standards, enhanced quality systems, and modern pharmaceutical manufacturing practices.
Upgraded 2025 Standards
100%
Batch Compliance Rate
10+
Years of Excellence
15+
Successful Audits
0
Major Deviations
100%
Batch Compliance Rate
10+
Years of Excellence
15+
Successful Audits
0
Major Deviations
Quality Management System
Comprehensive quality framework ensuring pharmaceutical excellence at every stage of manufacturing and distribution
Quality Assurance (QA)
- Enforcing strict cGMP compliance standards
- Driving continuous process improvement initiatives
- Training workforce for quality excellence
- Ensuring consistent regulatory and product compliance
Quality Control (QC)
- Testing APIs and finished products
- Ensuring purity, safety, and effectiveness
- Verifying packaging and material standards
- Releasing products after full analysis
Batch Control
- Complete batch traceability from raw material to distribution
- Batch manufacturing records (BMR) documentation
- Electronic batch review and approval system
- Batch release protocol and certificate generation
Continuous Improvement
- CAPA (Corrective and Preventive Action) system
- Risk-based quality management approach
- Employee training and competency assessment
- Regular internal and external audit programs
Our Quality Commitment
At Delwis Healthcare, quality is embedded in our organizational culture and extends across every function. From manufacturing to management, every team member is accountable for maintaining pharmaceutical quality standards and regulatory compliance.
Our Quality Management System (QMS) follows ICH guidelines and global best practices to ensure patient safety, product efficacy, and consistent quality across domestic and international markets.
Through continuous monitoring, validation, and improvement initiatives, we maintain a zero-tolerance approach to quality deviations, while driving innovation, compliance, and operational excellence in pharmaceutical manufacturing.
Comprehensive Compliance Coverage
Our regulatory affairs team provides end-to-end support for pharmaceutical compliance, from pre-approval to post-market surveillance
Trusted by Regulatory Authorities Worldwide
Our manufacturing facilities and quality systems are regularly inspected and approved by national and international regulatory authorities, ensuring consistent compliance and global acceptance.
Quality & Regulatory Inquiries
Get expert support for quality audits, compliance questions, and regulatory matters
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