Tel. +43 676 5345614
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.
office@kamosys.eu
We own a GMP certificate & a manufacturing licence
Start from your role. Move faster from there.
Every pharmaceutical program faces different pressure points. Choose your perspective and see how Kamosys supports your path.
Built around the real journey of a pharmaceutical product
Every pharmaceutical program faces different bottlenecks as it moves from early development to GMP manufacturing, batch release, and scale.
Start where you are. Solve what is slowing you down. Prepare for what comes next..
Explore solutions along the supply chainGMP FOUNDATION
Build the right quality system from the start >>>
DATA AND DOCUMENT READINESS
Build compliant structures without building unnecessary complexity >>>
MANUFACTURING QUALITY ACCELERATION
Prepare operations, documentation, and quality oversight before clinical
supply becomes a bottleneck >>>
BATCH RELEASE AND QP SERVICES
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.
Structured services that move you forward
Kamosys translates complex pharmaceutical requirements into clear, outcome-driven service packages aligned with your stage and needs.
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
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
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
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. GMP Certificate
Operational Release Capability
Hands on batch release support with practical execution focus. Manufacturing Licence
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
Unlike many quality consultancies, Kamosys operates under its own manufacturing license for biologics and is responsible for the complete quality oversight of Phase I clinical manufacturing. This operational experience shapes every recommendation we make.
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
Kamosys helps you develop an operating model that grows alongside your organization. This enables faster decision-making, confident inspections, and sustainable success throughout the entire pharmaceutical lifecycle.
