• Partners

HSC (Germany) ,

Institute of Clinical Research,

First Clinical Research LLC,

GCP Association,

International Biopharmaceutical Association









GMP audit



GMP – GMP facility audit to FDA and EMEA requirements

GTP – Tissue engineering, cell therapy and tissue bank audits

Internal audit system development


 Evaluation of Sponsor and Contract Clinical Supply Operations

  • QA/QC system evaluations

  • Product complaint investigations

  • Labeling

  • Storage and distribution

  • GMP record and report requirements

Regulatory agency audit response formulation and remediation: 

(PMA, PAI, 483, Consent decree, Recalls, Warning Letters and Market withdrawals, etc.)


Quality systems assessment, risk, assessment, design and implementation; Needs/Gap analysis


Process and scale-up validation


Equipment Qualification/Validation


Computer validation


Facility design


Environmental monitoring


Utility and facility design and monitoring


Management strategies for compliance systems


Training of employees to GLP’s/GMP’s; Beginner, Intermediate, Advanced levels; Group or individual


Quality systems integration and harmonization: For difficult, combination products and/or multiple quality systems requirements


Vendor and supplier audits – GLP/GMP vendor qualification


Documentation and batch record systems development


Review and development of SOP’s


21 CFR Part 11 compliance


CAPA/Deviation systems development


Stability Program implementation


GMP Regulatory Service Offerings:


Regulatory filing preparation and filing








Recall, Adverse Event and Complaint systems implementation

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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