asertain® Validation Services for Filters & Single Use Systems

asertain® Validation Services for Filters & Single Use Systems
Product Description

Your Trusted Partner in Ensuring Regulatory Compliance
Since 2008, mdi has been a trusted partner to the pharmaceutical and biopharma industries, providing asertain® validation services that support the regulatory approval of drug products. Our extensive experience spans a wide range of formulations, including conventional injectables, ophthalmic drugs, oncological treatments, emulsions, and novel drug delivery systems (NDDS) such as liposomal and depot formulations (solvent phase). 
We also specialize in validating plasma proteins and recombinant proteins, including insulin, GCSF, monoclonal antibodies (mAbs), and more.

Advanced Microdevices Private Limited

  • Country/Region:
    India
  • On CPHI since:
    2022
  • Certificates:
    1
  • Employees:
    1000 - 4999
Company types
Manufacturer/Innovator
Primary activities
Other
Specifications
  • Details
    mdi’s asertain® validation services are tailored to meet specific customer requirements while ensuring alignment with regulatory expectations. These services are critical for the validation of sterilizing grade filters as well as any single use components in contact with process fluids such as media, buffers, and drug substance–drug product (DS–DP) solutions.

  • Selling Points
    International Approvals/Standards; Prompt Delivery; Quality Service
  • Supplied from
    India

Advanced Microdevices Private Limited

  • Country/Region:
    India
  • On CPHI since:
    2022
  • Certificates:
    1
  • Employees:
    1000 - 4999
Company types
Manufacturer/Innovator
Primary activities
Other

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