Quality is our
Core Identity.
We ensure patient safety through rigorous auditing, strict regulatory adherence, and unwavering commitment to GDP standards.
Status
100% Compliant
GDP Compliant
Adhering to Good Distribution Practices to maintain product integrity during transport across all climatic zones.
Rigorous Audits
Comprehensive on-site verification of manufacturing facilities ensuring adherence to global GMP standards.
Regulatory Support
End-to-end dossier support including DMFs, COAs, and stability data for smooth market authorization.
ISO 9001:2015
Certified.
Our quality management system is audited annually to ensure continuous improvement and strict adherence to international standards.
- Risk-based thinking approach
- Evidence-based decision making
Compliance Frameworks
EU GDP Guidelines
Directive 2013/C 343/01
FDA 21 CFR Part 11
Electronic Records Compliance
WHO TRS
Technical Report Series
Our Audit Process
A systematic approach to vendor approval.
Pre-Assessment
Initial documentation review & questionnaire.
On-Site Audit
Physical inspection of manufacturing & QC labs.
CAPA Mgmt
Corrective actions & follow-up on findings.
Approval
Final addition to Approved Vendor List (AVL).
Data Privacy & Security
Protecting sensitive intellectual property is paramount. We implement rigorous cybersecurity measures including NDAs and encrypted transmission.