GMP audit

Auditing:

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

IND

NDA

ANDA

510(k)

PCA

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.