Quality & Compliance

Every dose is a promise — we uphold the highest standards of safety, precision, and regulatory integrity

Committed to precision, safety & trust

Mi-Dose Pharma operates under rigorous quality frameworks. From raw material sourcing to final packaging, every step is monitored, validated, and documented. We don't just meet regulations — we exceed them.

GMP & GLP

Our facilities adhere to Good Manufacturing Practice and Good Laboratory Practice guidelines, ensuring every batch is consistent and pure.

WHO-GMP ISO 9001
Stability & Testing

Rigorous stability studies and in-house microbiological testing guarantee that each product retains its efficacy throughout its shelf life.

ICH Q1A USP
Regulatory Compliance

We work hand‑in‑hand with DCGI, CDSCO, and international regulators to ensure transparent, timely, and compliant documentation.

NDA / ANDA CTD format
Audit & Traceability

Every ingredient and process is traceable. Our internal audit teams conduct regular reviews to maintain zero-defect production.

CAPA Batch trace

Quality is not a department — it's a culture. At Mi-Dose, compliance is woven into every decision, from R&D to the patient's hand.

Quality control lab at Mi-Dose

In-house quality assurance

Our state‑of‑the‑art quality control lab performs more than 200 tests per batch. From dissolution to assay, every parameter is verified to ensure that each dose meets the highest pharmacopoeial standards.

Certified & accredited
ISO 13485 GMP certified WHO prequalified