NEB Pharmaceutical Consulting
Consulting firm providing quality and compliance services to life sciences organizations. Offers GxP quality management, auditing, regulatory document review and medical writing, clinical operations support, vendor oversight, and GxP training with experience across global regulatory frameworks and multiple therapeutic areas.
Industries
Nr. of Employees
small (1-50)
NEB Pharmaceutical Consulting
Services
Consulting to establish and manage quality systems, master audit plans, SOPs, change control, personnel training, and GxP audits across clinical, laboratory, and manufacturing domains.
Quality review and QC of regulatory submission documents and drafting/editing of safety narratives and regulatory filing sections in collaboration with subject matter experts.
Support for implementing GCP SOPs, vendor/CRO vetting, risk management, quality agreements, and vendor oversight for clinical studies.
Training courses covering inspection readiness, GCP, GDP, GLP, GMP, GVP and general GxP overviews for global staff.
Consulting to establish and manage quality systems, master audit plans, SOPs, change control, personnel training, and GxP audits across clinical, laboratory, and manufacturing domains.
Quality review and QC of regulatory submission documents and drafting/editing of safety narratives and regulatory filing sections in collaboration with subject matter experts.
Support for implementing GCP SOPs, vendor/CRO vetting, risk management, quality agreements, and vendor oversight for clinical studies.
Training courses covering inspection readiness, GCP, GDP, GLP, GMP, GVP and general GxP overviews for global staff.
Expertise Areas
- Quality management systems
- GxP auditing and compliance
- Regulatory submission review
- Inspection readiness
Key Technologies
- GxP frameworks (GCP, GLP, GMP, GCLP, GVP)
- Regulatory submission documentation (IND, NDA, BLA, briefs)
- CIOMS-format safety narratives
- Audit management programs