From ambition to achievement, Noor Consulting can assist in establishing a Quality Management System that integrates and aligns your product development requirements with your compliance and business sustainability.–Noor Consulting International
Quality Systems
Program Management
Pharmaceutical
Medical Devices
Pharmaceutical Consulting
- Quality System Development
- FDA 483 Response Support
- IND/NDA/ANDA Review
- Process / Equipment/ Cleaning Validation
- Formulation / Stability Studies Support
- Pre-Approval Inspection Support
- Analytical Method Development / Validation
- CMC Development Support
- Training Program Development
- cGLP / cGCP / cGMP Compliance Support
Medical Device Consulting
- Design documentation services
- Third-Party & Due Diligence Audits
- CAPA Development/Investigation Support
- Compliance Gap Assessments
- Document Control / Change Management
- Clinical Study Development Support
- Part 11 / HIPAA Compliance Support
- Strategic Compliance and Risk Management
- Notified Body Choice and Liaison
- 510(k), PMA, IDE, CE-mark for Class I, II and III devices
