The commitment to consolidate a Quality Culture within the company continues. Substantial investments in robust regulatory and quality systems ensure reliability in the development, manufacture, and supply of products & devices. The Documentation includes:

• Device History Record
• Device Master Record
• Design history file
• Risk Management
• Mould and Machine Validation covering DQ, IQ, OQ, PQ
• Product Testing and Validation as per the apt standards
• EU directives for CE Marking, USA Type III DMF
• Full batch documentation with Digital Batch Manufacturing Record

Electronic BMR & Bar code system provides quicker retrieval, easy Identification, and traceability of products, raw materials, machine, mold, and other manufacturing details, etc. of the manufactured batch. Most of the products have Type III Drug Master File & CE mark. At Doctor Pack, we have an extensive exposure to the preparation and submission of apt documents for DHF, ‘CE’ marking, ‘Type-III DMFs’, and the 510 K (Pre-market Notification) requirements.