The fastest route to GMP readiness and confident release
Kamosys helps biotech and pharmaceutical teams build GMP-ready operations and accelerate manufacturing readiness.
Through quality expertise, operational support, and digital tools, Kamosys enables teams to release batches with confidence.
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I am Founder or CEO
I lead Quality
I lead Manufacturing
I lead Operations
I am a Qualified Person
Built around the real journey of a pharmaceutical product
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Process Knowledge and Data Foundation
Capture the right data early and create the basis for scalable quality decisions
GMP Documentation and QMS
Build compliant structures without building unnecessary complexity
Manufacturing Readiness
Prepare operations, documentation, and quality oversight before clinical supply becomes a bottleneck
Batch Release
Release with confidence, speed, and traceable decision making
Scale and Inspection Readiness
Strengthen systems for growth, audits, partners, and regulators
What clients gain
Reduce time to GMP readiness.
Avoid quality bottlenecks before clinical manufacturing.
Build inspection ready systems without a full internal department.
Release batches with confidence and speed.
Connect process data, documentation, and quality decisions in - one operating model.
1. GMP Foundation
For startups or new programs that need to establish GMP structures in a pragmatic way.
Includes: QMS basics, SOP structure, documentation framework, role model, QA setup
2. Data and Document Readiness
For teams that need to seamlessly integrate data and documents.
Includes: METIS, TEMIS, structured documentation, traceability, data integrity support
3. Manufacturing Quality Increase
For companies involved in technology transfer, GMP manufacturing, or clinical care.
Includes: readiness checks, batch documentation review, QA oversight, deviation readiness, operational support
5. Scale Up Quality Operations
For growing companies facing audit, partner, or inspection pressures.
Includes: inspection readiness, process governance, quality scaling, digital enablement, remediation support
4. Clinical Batch Release Readiness
For companies that need to establish approval processes securely and quickly.
Includes: QP support, release workflows, documentation review, release decision support
Why Kamosys
Most providers focus on either quality, release, or software. Kamosys connects all three.
GMP Quality Expertise
Deep understanding of compliant operations in biotech and pharma environments
Operational Release Capability
Hands on batch release support with practical execution focus
Digital Process Intelligence
Digital tools that connect process data, documentation, and quality decisions
- GMP Certificate and Manufacturing Licence for biologics
- expertise in biosimilars and personalized medicine
- experience with CHO and HEK based processes
- Excel based GxP pragmatic solutions where useful
- Annex 11 and CFR Part 11 awareness
- strong bridge between operations and compliance
Contact us about anything related to our company or services.
We'll do our best to get back to you as soon as possible.
- Kamosys GmbH
- 7343 Neutal, Theodor Kery Strasse 55
- +43 676 5345614
- office@kamosys.eu
