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Documentation & QMS

We design SOP frameworks, batch records, validation master plans (VMP), and risk assessments (RA-ENG, FMEA). Our services include qualification protocols (IQ/OQ/PQ), CAPA systems, and data integrity compliance.
With Medora Solution, documentation becomes more than paperwork — it’s a compliance tool and an efficiency driver.

Pharma SOP and documentation services – Medora Solution

Machinery Troubleshooting

We troubleshoot and optimize filling & capping machines, FFS lines, sterilizers, WFI/PW systems, and utilities. Our approach combines on-site technical expertise with long-term reliability improvements.
We minimize downtime, reduce recurring issues, and ensure your machinery runs at full performance.

Pharmaceutical machinery troubleshooting and maintenance – Medora Solution

Spare Parts & Imports

We source parts and components directly from qualified vendors in China and the EU. Our services cover vendor qualification, RFQs, logistics, and customs clearance.
Clients benefit from reduced costs, faster delivery, and guaranteed compliance with GMP expectations.

Pharma spare parts and imports services – Medora Solution

Production Line Solutions

We deliver full support for new production lines and system upgrades. Services include URS preparation, FAT/SAT, installation, commissioning, and IQ/OQ/PQ qualification.
With Medora Solution, every line is delivered audit-ready, validated, and optimized for performance.

Pharmaceutical production line installation and validation – Medora Solution

Regulatory & Training

We provide tailored GMP/cGMP training programs (operators to management) and guidance for regulatory submissions and renewals.
Our expertise ensures your teams are inspection-ready and your facility remains aligned with evolving regulations.

Pharma GMP regulatory training and consultancy – Medora Solution

Quality & Compliance

We support internal/external audits, deviation and OOS handling, cleaning validation, and governance improvements.
Our services reduce compliance risk, build inspector confidence, and streamline documentation workflows.

Pharmaceutical quality and compliance audits – Medora Solution

API & Raw Materials Supply

We supply APIs, excipients, and specialty raw materials from qualified vendors. All suppliers undergo compliance checks and documentation review.
Medora Solution ensures smooth procurement and logistics, reducing supply risk and supporting your manufacturing schedule.

API and raw material supply for pharmaceutical industry – Medora Solution
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