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We support our clients through every stage of the drug and medical device regulatory lifecycle.
Regulatory Affairs
Quality Assurance
We provide a comprehensive range of QA services to ensure your product reaches the market safely and in full compliance. Our offerings include certified auditing, QMS setup, and complete QP activities.
Lab Services
Our GMP-certified laboratory provides comprehensive analytical testing for pharmaceutical raw materials, excipients, and finished product release.
Qualification & Validation
We ensure your products meet quality standards and regulatory requirements by qualifying and validating your equipment, facilities, and processes.
Vigilance
QbD Group provides a comprehensive global service called One Vigilance, combining scientific methodologies, proprietary tools, and expert teams in Pharmacovigilance, Biopharmacovigilance, and Medical Device Vigilance.
Clinical
We are a leading clinical solutions provider, specializing in medical devices and biotech, offering global CRO services and expert consultancy.
Software Solutions & Services
Our solutions include a cloud-based, pre-validated QMS tailored for life sciences, along with eIFU services to digitalize paper Instructions For Use (IFU). We also offer comprehensive services in Computer System Validation and Digital Health.
Toxicology
We provide a full range of toxicology services tailored to your processes, applications, and equipment. As EUROTOX-certified professionals and proud members of AETOX, we bring expertise and reliability to every project.
Regulatory Affairs
Regulatory Affairs
We support our clients through every stage of the drug and medical device regulatory lifecycle.
Pharma
Pharma
MD
Medical Devices
IVD
In Vitro Diagnostics
RA Strategy for Pharma
Drug Development
Early Development
Scientific Advice
Performance Evaluation Studies
Regulatory Procedures
Submissions
eCTD Publishing
Artwork and Labeling
Linguistic Services
Vigilance (Pharmacovigilance)
Combination Products
Information Officer (Promotional Materials)
Orphan Diseases
Regulatory Intelligence
RA Strategy for MD & IVD
Product Development / Design and development
Legal Representative
Technical Documentation
Notified Body Submissions
Liaison with the notified bodies
Lifecycle management / PMS
Person Responsible for Regulatory Compliance (PRRC) for IVD
PRRC
In-country Representative Services
Vigilance (Materiovigilance)
Companion diagnostics (CDx)
Quality Assurance
Quality Assurance
We provide a comprehensive range of QA services to ensure your product reaches the market safely and in full compliance. Our offerings include certified auditing, QMS setup, and complete QP activities.
Pharma
Pharma
MD
Medical Devices
IVD
In Vitro Diagnostics
QMS Setup
QMS Support
QMS Remediation
Qualified Person (QP)
Annual Product Review (APR) / Product Quality Review (PQR)
Audits & Remediation
Monitoring Studies
Impurities
Toxicology Reports
PDE & HBEL Reports
Lab Services
Lab Services
Our GMP-certified laboratory provides comprehensive analytical testing for pharmaceutical raw materials, excipients, and finished product release.
Pharma
Pharma
MD
Medical Devices
IVD
In Vitro Diagnostics
QC Chemical Analysis
Method Development
Method Validation
Stability Testing
Cleaning Validation
Microbiological Services
Environmental Monitoring
QP Batch Release
Elemental Impurities
R&D Projects
Qualification & Validation
Qualification & Validation
We ensure your products meet quality standards and regulatory requirements by qualifying and validating your equipment, facilities, and processes.
Pharma
Pharma
MD
Medical Devices
IVD
In Vitro Diagnostics
Commissioning
Facility Qualification
Utility Qualification
Equipment Qualification
Process Validation
Cleaning Validation
Analytical Method Validation
Sterilization Validation
Computer System Validation (CSV)
Tech Transfer
Process & Product Support
Vigilance
Vigilance
QbD Group provides a comprehensive global service called One Vigilance, combining scientific methodologies, proprietary tools, and expert teams in Pharmacovigilance, Biopharmacovigilance, and Medical Device Vigilance.
Pharma
Pharma
MD
Medical Devices
IVD
In Vitro Diagnostics
ICSR Management
Tracking Adverse Drug Reactions
Vigilance & Pharmacoviglance Hotline Services
EudraVigilance Medicinal Product Dictionary (XEVMPD)
Aggregate Safety Reporting
Project Management
Regulatory Intelligence
Strategic Planning
Safety Signal Program
Pharmacovigilance QMS & Pharmacovigilance System Master File (PSMF)
Certified PV Audits, Mock Inspections & Activities ISO
QPPV / Local Representative
Pharmacovigilance & Certified Blended Training
Literature monitoring search solutions and alerts and a set of medical Information solutions
Clinical
Clinical
We are a leading clinical solutions provider, specializing in medical devices and biotech, offering global CRO services and expert consultancy.
Pharma
Pharma
MD
Medical Devices
IVD
In Vitro Diagnostics
Clinical Study Operations
Data Management and Analysis
Clinical Safety Management
Clinical Pharmacovigilance Service
Clinical Regulatory
Clinical Quality
IVD CRO
PMCF/PMPF
Medical Writing for MD
Medical Writing for IVD
Clinical Strategy Support
Clinical Study Design Report
Clinical Expert Services
Software Solutions & Services
Software Solutions & Services
Our solutions include a cloud-based, pre-validated QMS tailored for life sciences, along with eIFU services to digitalize paper Instructions For Use (IFU). We also offer comprehensive services in Computer System Validation and Digital Health.
Pharma
Pharma
MD
Medical Devices
IVD
In Vitro Diagnostics
Scilife
E-Labeling / IFUcare
Medical Device Software Compliance
AI/ML Compliance
Data Governance
Digitalization
Software Validation, Central IT Systems
Data Integrity
Software Implementations
IT Infrastructure Qualification
Paperless Validation
Operational Software Compliance
Toxicology
Toxicology
We provide a full range of toxicology services tailored to your processes, applications, and equipment. As EUROTOX-certified professionals and proud members of AETOX, we bring expertise and reliability to every project.
Pharma
Pharma
MD
Medical Devices
IVD
In Vitro Diagnostics
PDE-OEL Reports
Nitrosamine Risk Assessment
Organic Impurities Reports
Extractables & Leachables Reports
Environmental Risk Assessment (ERA)
Monitoring Studies
Get in touch
Need support to achieve excellence and drive success? Don't hesitate to contact us.
