Portfolio of Biotech Services

At Bio International Convention in San Diego, US the Midas Biotech- and Services-Team will present its Portfolio of Biotech Services as shown below.

Midas Services for the Biopharmaceutical Industry

  • Preclinical Development

    Sourcing & Supply of:

    • Raw materials, starting materials & intermediates (mRNA,
      TIDES, payload, linkers) for biopharma
    • Reference product for analytical comparability
      (full documentation package)

    Procurement of qualified and experienced CDMOs for:

    • Cell-line development
    • Drug substance manufacturing

    (Optional services for tech transfer and project management.)

  • Clinical Development, going for Marketing Authorization

    Sourcing & Supply of:

    • Comparators (reference product, active comparator) & co-medication for clinical trials

    Procurement of qualified and experienced CDMOs for:

    • Clinical trial manufacturing (IMP), incl. distribution
    • Drug product manufacturing/commercial fill & finish
    • Labelling and packaging

    (Optional services for tech transfer and project management.)

    Supply Chain Management:

    • Clinical supply chain management
    • 2-8°C storage & logistics
    • Direct-to-patient distribution

    Quality Services:

    • Auditing service/Supplier qualification
    • Inspection support (mock inspections, remediation &
      process improvements as outcome of the mock)
    • Gap analyses & optimization of QMS
    • EU Import of biotech products (IMPs)
    • QP release of IMP (in-house EU QP)

    Regulatory Services:

    • Support in scientific advice procedures
    • Dossier/IMPD evaluation, writing clinical & non-clinical overviews
    • Compilation and publishing (in-house eCTD publishing)
    • Submission management & communication with authorities

    Licensing services:

    • Identification of potential partners in global Midas network
    • Support for out-licensing, partnering and dealmaking activities
    • Third-party due diligence support
    • Asset evaluation and mock due diligence assessments
  • Launch and Commercial Supply

    Supply Chain Management:

    • Launch preparation
    • Setup and management of the supply chain
    • 2-8°C storage & logistics
    • Order handling/forecasting & demand planning
    • Local US agent for US commercial import and distribution
    • Import/Export services


    • Customer service
    • Complaints & returns
    • EU Wholesale release (In-house WRP)
    • Warehouse & stock management incl. last mile distribution
    • Re-packaging/Re-labelling, doctor sample production

    Pharmaceutical Responsibility:

    • EU-GMP compliant pharmaceutical importation
    • EU market release/certification (in-house EU-QP)
    • Acting as Marketing Authorisation Holder (MAH)
    • Comprehensive pharmacovigilance services (in-house EU-QPPV)

    Quality Services:

    • Manufacturing batch record review & QP certification
      (EU QP release to market, Annex 16 Appendix II)
    • QP confirmation of partial manufacturing
      (Release for further processing, Annex 16 Appendix I)
    • Management of bonded warehouse (site of physical importation)
    • Change control, complaint handling, recall processing
      by Midas global QM

    Regulatory Services:

    • Regulatory maintenance
      (variations/supplements, extension applications, renewals)

Midas Pharma is also active in the field of pharmaceutical biotechnology and benefits enormously from its global network in the life science sector. Midas offers a broad portfolio of biopharmaceutical ingredients, such as cell lines, materials for clinical trials and commercial purposes, which are produced at GMP-compliant sites.

In addition, Midas supports its partners with services such as analytical QC testing for R&D and batch release of biotech products, as well as a variety of quality, regulatory and PV services.

If you want to know more about our service portfolio meet us at Booth 4217 Bio International Convention.

We look forward to meeting you there.

Your Contact

Martin  Baur

Martin Baur

Biotech & Services
Senior Director Biotechnological Services

Midas Pharma GmbH
Rheinstraße 49
55218 Ingelheim am Rhein
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