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Regulatory Affairs.

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GMP.

Ensure compliant operating procedures in accordance with GMP specifications.

Computer System Validation.

Optimize the validation of your computer-aided systems.

ISO 13485 QM system.

Secure your certification with a robust QM system.

IVDR readiness.

Prepare your products for the IVDR in good time.

MDR readiness.

Ensure the conformity of your medical devices according to MDR.

Good Laboratory Practice.

Ensure the quality of your non-clinical studies according to GLP standards.

Clinical Affairs.

Optimize your study processes for smooth admission.

GCP (Clinical Trial).

Optimize your clinical quality management for successful studies.

Audit GxP / ISO.

Improve your audit processes permanently with expert knowledge.

Deviation Management.

Increase efficiency with targeted deviation management.

CAPA Management.

Optimize your processes with a strong CAPA system.

Lean Lab.

Make your laboratories more efficient with practical lean strategies.

CAPEX.

Save costs through efficient investment planning.

Digital Governance.

Ensure your compliance and cyber security.

Pharmacovigilance.

Improve the safety of your products.

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Overview
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Audits
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Overview
Quality Management
MDR readiness
IVDR readiness
ISO 13485 QM system
Good Laboratory Practice
Digitisation
Deviation management
Clinical Affairs
CAPEX
CAPA Management
Pharmacovigilance Consulting
GCP (Clinical Trial)
Good Manufacturing Practice
Computer System Validation
Lean Lab
Regulatory Affairs
Data Integrity Assurance
Audits
Digital governance

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Overview
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IVDR readiness.

MDR readiness.

Good Laboratory Practice.

GCP (Clinical Trial).

CAPA Management.

Pharmacovigilance.

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