Quality
ICH Q10 aligned,
full in-house QC,
multinational certifications.
Quality Management
Our Quality Management System is aligned with ICH Q10, incorporating risk-based thinking, and robust CAPA systems. It governs the entire product lifecycle — from design and development to production, release, and post-marketing oversight.
Certifications & Compliance
HELP’s facility holds EU-GMP and ISO 13485 certifications. We are also certified by third countries including Canada, Australia, UAE, and the EAEU. Our systems undergo regular audits by regulatory bodies and our partners to ensure ongoing compliance.
Quality Control
Our modern QC laboratory offers full in-house testing of raw materials and finished products.
We perform method validation and method transfer, ICH stability studies, photostability testing, and microbiological analysis.