BAG Health Care
BAG Health Care GmbH is a pharmaceutical contract manufacturer based in Europe with over 50 years of experience. They specialize in aseptic filling, lyophilization, analytical services, secondary packaging, regulatory compliance, and technology transfer. Their mission is to deliver high-quality, compliant, and innovative solutions for sterile drug manufacturing, supporting clients from development to commercial launch with a focus on small and midsized batches. Their vision is to be a reliable, patient-centered partner in the pharmaceutical industry, ensuring uninterrupted patient care through responsive and flexible manufacturing services.
Industries
Nr. of Employees
medium (51-250)
BAG Health Care
Services
GMP-compliant aseptic filling and finish of sterile parenteral vials, covering tech transfer, validation, and production from early-phase through commercial batches.
GMP-qualified freeze-drying services for biologics, peptides and solvent-containing formulations with multiple dryer sizes to support development and commercial batch volumes.
In-house analytical laboratory services for raw material testing, release and stability testing, method development and transfer, with audited partner support for specialized assays.
Labeling, boxing, carton packaging and GMP-compliant storage across controlled temperature ranges; includes support for EU serialization requirements for clinical and small commercial batches.
Regulatory support including GMP compliance, Annex 1 adherence, Qualified Person (QP) batch release, CCIT and 100% visual inspection, validation support and documentation for audit-readiness.
Structured technology transfer and project management from kickoff to commercial launch including gap analysis, risk-based assessments, timeline management, deviation handling and submission coordination.
GMP-compliant aseptic filling and finish of sterile parenteral vials, covering tech transfer, validation, and production from early-phase through commercial batches.
GMP-qualified freeze-drying services for biologics, peptides and solvent-containing formulations with multiple dryer sizes to support development and commercial batch volumes.
In-house analytical laboratory services for raw material testing, release and stability testing, method development and transfer, with audited partner support for specialized assays.
Labeling, boxing, carton packaging and GMP-compliant storage across controlled temperature ranges; includes support for EU serialization requirements for clinical and small commercial batches.
Regulatory support including GMP compliance, Annex 1 adherence, Qualified Person (QP) batch release, CCIT and 100% visual inspection, validation support and documentation for audit-readiness.
Structured technology transfer and project management from kickoff to commercial launch including gap analysis, risk-based assessments, timeline management, deviation handling and submission coordination.
Expertise Areas
- Aseptic fill-and-finish for vials
- Lyophilization and freeze-drying scale-up
- Analytical testing and method development for parenterals
- Regulatory compliance and QP batch release
Key Technologies
- Aseptic vial filling systems (rotary and piston filling)
- Lyophilization (freeze-drying)
- HPLC (UV/VIS, DAD)
- Karl Fischer titration
News & Updates
Too small, not worth the effort. BAG specializes in handling small batch production for niche, high-value drugs, ensuring availability and readiness for critical needs.
BAG provides validated terminal sterilization for medical devices under EU MDR 2017/745, ensuring compliance and regulatory readiness.
BAG emphasizes strategic, pragmatic, and client-centric quality assurance in GMP manufacturing, embedding QA professionals in product lifecycle management.
Installation of a new 8 m² HOF freeze dryer and infrastructure upgrades to support future-ready lyophilization services.
Too small, not worth the effort. BAG specializes in handling small batch production for niche, high-value drugs, ensuring availability and readiness for critical needs.
BAG provides validated terminal sterilization for medical devices under EU MDR 2017/745, ensuring compliance and regulatory readiness.
BAG emphasizes strategic, pragmatic, and client-centric quality assurance in GMP manufacturing, embedding QA professionals in product lifecycle management.
Installation of a new 8 m² HOF freeze dryer and infrastructure upgrades to support future-ready lyophilization services.