Analytical and Phy-Chem Department

Analytical and Phy-Chem Department
Product Description

  • Setup and development of analytical methods
  • Analytical support to formulation and process studies
  • QC testing of batches involved in in-vivo studies and supervision of bioanalysis
  • QC Testing of GMP batches
  • Microbiology (monitoring of GMP Pilot Plant)
  • Non-GMP and GMP activities

Ascil Biopharm

  • ES
  • 2021
    On CPHI since
  • 1
    Certificates
  • 25 - 49
    Employees
Company types
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Manufacturer
Laboratory Services
Laboratory, Analytical, Biotechnology Equipment
Medical Devices
Packaging & drug delivery
Technology

Ascil Biopharm

  • ES
  • 2021
    On CPHI since
  • 1
    Certificates
  • 25 - 49
    Employees
Company types
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Manufacturer
Laboratory Services
Laboratory, Analytical, Biotechnology Equipment
Medical Devices
Packaging & drug delivery
Technology

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    • Compatibility studies and preformulation • Formulation and lab-scale batches • Definition and supervision of in-vivo studies • Non-GMP and GMP activities • Med-Tech workshop for device prototyping
  • GMP Pilot Plant

    Product GMP Pilot Plant

    • Manufacturing of pilot /scale-up batches • Manufacturing of GMP and clinical batches • Preparation of clinical kits
  • QA Department

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    • Overall QA system • Internal and external audits
  • QP, Tech Direction and Regulatory

    Product QP, Tech Direction and Regulatory

    • Supervision of GMP activities • Release of GMP and clinical batches • Relationship with agencies • Consolidation and maintenance of regulatory documents