• Partners

HSC (Germany) ,

Institute of Clinical Research,

First Clinical Research LLC,

GCP Association,

International Biopharmaceutical Association

 

 

 

 

 

 

 

GCP audit


ICH GCP audit services
NBScience Quality Management provides services in QA/QC such as evaluation of trial conduct and compliance with ICH GCP audits, Helsinki Declaration, Protocol, SOPs and any applicable local/international regulatory requirement to ensure confidence in data quality and to identify opportunities for process improvement.

GCP audits:
- Sponsor company - e.g. system audits, trial audits of sponsor suppliers and audit of IT systems
- Investigational sites

QA consultancy and support sponsor staff in:
- SOP design, development & implementation
- Quality system development

ICH GCP audits training:
- Sponsor company - Staff and CRAs
- Investigators and research nurses

Compliance GMP, GCP, GLP, QSR and/or Part 11/Systems Audit

Quality Assurance Audits  -  Quality System Audits - Part 820

SOPs, Quality Assurance and Standards Audits

GMP - Good Manufacturing Practice Audit

GCP - Clinical Audits - Regulatory Audits

Equipment Validation Documentation Audit

Software / Systems Validation Audits

Vendor & Supplier Audits

CROs, Investigators, Monitors, and Study Sites

Database Audits, SAS, CMMS, eDC, DM, eCFR

 

Certified GCP, cGMP Auditors:

Auditor 1

Auditor 2

Auditor 3

 

Contact us


 

 

The success of the NBScience international is built on forging profitable business relationships between the Pharmaceutical and Biotechnology industries and their partners in clinical research.
With our 5 years of experience in increasing our partners' return on investment we've developed winning strategies guaranteed to build and sustain successful partnerships in clinical trials outsourcing.

  • pharmaceutical companies
  • CRO
  • Investigators
  • GCP,cGMP auditors

 

NBScience already has many partnerships with societies, universities, statutory organisations and NGOs locally, nationally and internationally. We aim to strengthen these relationships and develop new collaborations in the future.

 

 

 

 

 

 

Clinical Trials Registry

 

Good Clinical Practice (GCP) Certification Program Participants List

 

 

 

NBScience international

 

 

 

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