Doctor Pack India Pvt Ltd | Bangalore | global healthcare, pharmaceutical, diagnostics companies, hospitals, retail pharmacies and contract packagers.

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Quality

Quality to us means more than just fulfilling minimum requirements as we build quality right from the design stage to the development and manufacturing process. Our commitment to the quality is evident by our credentials such as ISO 15378 for Primary Packaging, ISO 13485 for Medical Devices, ISO 14001 for EMS, ISO 45001 for Occupational Health & Safety (OH&S), CE Marking & Type III DMF.  

 

Our labs are well equipped for product & process validation. Our processes are designed for traceability and controls. Doctor Pack products comply with USP, EP, JP & other regulatory standards. We have a good exposure to the preparation and submission of apt documents for MDD, CE marking, Type-III DMF, DMR, DHF, DHR, 21 CFR 820 and the 510 (k) requirements.

 

Doctor Pack provides IPR protection and Patent support to each customer. We are well accustomed to strict demands on quality, timing and production. This gives Doctor Pack a competitive edge as a world-class development and supply partner for your pharma packaging & device needs.

 

incoming-testing Product Testing Metrology Lab precise thickness measurement
Incoming Testing Product Testing Metrology Lab Precise Thickness Measurement

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

  • Device Master File
  • Device History file
  • Mould and Machine Validation covering DQ, IQ, OQ, PQ
  • EU directives for CE Marking
  • Full batch documentation with our Batch Manufacturing Record

Bar code system provides easy traceability of products, raw materials etc. Batch records are retained for minimum of five years, and most of the products has CE Marking and are listed in a type III Drug Master File, 510 K and the Facility registration with the USA FDA is in the process.  At Doctor Pack, we have an extensive exposure to the preparation and submission of apt apt documents for MDD, CE marking, Type-III DMF, DMR, DHF, DHR, 21 CFR 820 and the 510 (k) requirements.

Quick Contact

Doctor Pack India Private Limited
#136, Bommasandra Jigani Link Road,
Bommasandra Industrial Area,
Bangalore 560 099. INDIA

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M : +91-9591665747, +91-9945235933