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 accreditations such as ISO 15378 for Primary packaging, ISO 13485 for Medical Devices, ISO 14001 for EMS, CE Marking & Type III DMF.

QSR as per 21 CFR 820, 21 CFR 210/211 are adapted and followed through out the Operations.

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.

Doctor Pack provides IPR protection 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

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 documents for ‘CE’ marking, ‘Type-3 DMFs’, and the 510 K (Pre-market Notification ) requirements.

Quick Contact

Doctor Pack India Private Limited
#24, Bommasandra Jigani Link Road,
Bommasandra Industrial Area,
Bangalore 560 105. INDIA

E : This email address is being protected from spambots. You need JavaScript enabled to view it.

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T : +91-80-27839534/35
M : +91.9591665747, 9945330592