End-to-end Solutions for Biologics & Combination Products

Midas Pharma accelerates the development of Biologics and Drug Device Combinations with experience and complementary pharmaceutical functions.

Midas offers a portfolio of products, solutions and know how in all stages of your product life cycle to the execution of defined tasks and functions.

This contributes to more speed and higher success rates – from pre-clinic to commercial in your projects.

From Pre-Clinic to Phase 1–3
- Intermediates for biopharma (mRNA, TIDES, payload, linkers)
- Selection and coordination of CMOs for development of
  - Cell-line
  - API process
  - Fill-finish process
- Selection of devices
- Sourcing & supply of RLDs (reference listed drugs)
- Manufacturing and packaging of clinical material, incl. distribution to CROs
- Medical services (answering medical questions related to clinical trials)
- Evaluation and compilcation of CMC part
- Support for all QA/QC related topics
- Take over of regulatory and quality responsibilities
- Importer & exporter of records
- Acting as approved pharmaceutical developer and manufacturer
Commercial Supply
- Coordination of the supply chain end-to-end, incl. assembly & sterilization of combination products and logistics
- Take over of pharmaceutical responsibilities:
  - Product release/certification
  - Acting as MA holder
  - QPPV and pharmacovigilance (PV) services
- Wholesale & distribution services in EU
- Outlicensing (USA, EU, China, South East Asia, LATAM)
- Product transfers

Benefits

From pre-clinic to commercial with more speed and higher success rates
Reduction of complexity by combining and coordinating all activities
Adding pharmaceutical, technical, regulatory and quality know how
De-risking your development by joining forces
One-Stop-Shop or Modular Service Offer

Your Contact

Dr. Matthias Bauch

Dr. Matthias Bauch

Biotechnology & Devices
Global Vice President

Midas Pharma GmbH
Rheinstraße 49
55218 Ingelheim
Germany

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