Our expertise

Qualification & Validation

Qualification & Validation

Quality Assurance

Quality Assurance

Regulatory

Regulatory Affairs

Clinical

Clinical

Quality Control

Quality Control

Software solutions

Software solutions

Go to market

Go to market

Software solutions

Cloud-based and pre-validated Quality Management Software built for the life sciences as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions for Use (IFU).
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Regulatory Affairs

We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle.
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Quality Control

Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products.
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Quality Assurance

We offer the full range of QA services necessary to get your product to market in a safe and compliant way including auditing from certified auditors, setting up a QMS, and all QP activities.
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Qualification & Validation

We guarantee that products meet quality demands and comply with regulation through the qualification & validation of your processes, equipment and software.
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Go to market

We help you launch your product to market by providing marketing and communication services, business development support and sales strategy.
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Clinical

We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy.
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Qualification & Validation

ATMP
Biotech
In Vitro Diagnostics
Medical devices
Small Molecules
IT Infrastructure Qualification
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Computer System Validation
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Data integrity
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Equipment Validation
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:

Quality Assurance

ATMP
Biotech
In Vitro Diagnostics
Medical devices
Small Molecules
Performance Evaluation Studies
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Device Compliance
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
QMS Consulting for IVD Companies
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
QP Services
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Audit Services
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Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Compliance Specialist
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Biotech:
In Vitro Diagnostics:
Medical devices:
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Regulatory Affairs

ATMP
Biotech
In Vitro Diagnostics
Medical devices
Small Molecules
Person Responsible for Regulatory Compliance (PRRC)
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Legal Representative Clinical Trials
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Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
In Country Representative Services
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Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Performance Evaluation Studies
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Device Compliance
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Regulatory Affairs for Medical Devices
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Regulatory Affairs for Pharma and Biotech
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:

Clinical

ATMP
Biotech
In Vitro Diagnostics
Medical devices
Small Molecules
Performance Evaluation Studies
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Device Compliance
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Clinical Training Services
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Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Clinical Consultancy Solutions
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Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Medical Writing
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
CRO Solutions
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:

Quality Control

ATMP
Biotech
In Vitro Diagnostics
Medical devices
Small Molecules
QP Release and EU Import
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Stability Studies
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Environmental Monitoring Services
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Microbiological Analysis
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Cleaning Validation
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Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Analytical Method Validation
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Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Chemical Analysis
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:

Software Solutions

ATMP
Biotech
In Vitro Diagnostics
Medical devices
Small Molecules
E-Labeling / eIFU
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Scilife
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:

Go To Market

ATMP
Biotech
In Vitro Diagnostics
Medical devices
Small Molecules
Strategy, Commercialization, Operations
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules:
Marketing & Communications
ATMP:
Biotech:
In Vitro Diagnostics:
Medical devices:
Small Molecules: