Our expertise

Qualification & Validation

Qualification & Validation

Quality Assurance

Quality Assurance

Regulatory

Regulatory Affairs

Clinical

Clinical

Quality Control

Quality Control

Software solutions

Software Solutions & Services

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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Industry
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Qualification & Validation

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Process & Cleaning
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Environmental Monitoring Services
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
IT Infrastructure Qualification
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Computer System Validation
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Data Integrity
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Equipment Validation
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:

Quality Assurance

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Clinical QA
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Performance Evaluation Studies
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Device Compliance
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
QMS Consulting for IVD Companies
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
QP Services
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Audit Services
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Compliance Specialist
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:

Regulatory Affairs

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

Clinical

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
Performance Evaluation Studies
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Device Compliance
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Clinical Training Services
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Clinical Staffing Solutions
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Medical Writing
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
CRO Solutions
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:

Quality Control

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
iATMP QP batch release
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
QP Release and EU Import
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Stability Studies
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Environmental Monitoring Services
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Microbiological Analysis
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Cleaning Validation
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Analytical Method Validation
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Chemical Analysis
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:

Software Solutions & Services

ATMP
Biotech
In Vitro Diagnostics
Medical Devices
Small Molecules
Digital Health
E-Labeling / eIFU
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:
Scilife
ATMP:
Biotech:
In Vitro Diagnostics:
Medical Devices:
Small Molecules:
Digital Health:

Go To Market

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