Masuu Global provides inclusive Quality & GMP services in compliance with current Industry & Global Health Authorities standards to Pharmaceuticals, Biopharmaceutical, Life-sciences, CDMO industries (Formulation and API).

Masuu Global Quality SMEs (leading industry & agency experts) has specialization to maintain manufacturing facility 100% compliance as cGMP, GLP and GDP requirements.

Masuu Team has done 100+ Successful cGMP, GDP, GLP and Quality Compliance Audits & participated as a Spokespersons in the international Audits (USFDA/WHO/EU/CANADA GMP etc.).

Expertise in Area of

API (STERILE AND NON-STERILE)
FORMULATION (STERILE AND NON-STERILE)
QUALITY SYSTEMS & CONTROL
COMPLIANCE AND REMEDIATION
REGULATORY AFFAIRS

Masuu Quality and GMP Support

Quality Systems Development (Production, Facilities and Equipment, Material, Packaging and Laboratory Control)
Data Integrity Compliance & Documentation
Regulatory Integration for Mergers and Acquisitions
Facility cGMP & Regulatory Audit

  • Technical Due Diligence Compliance Audit
  • Mock Audit for Pre-Approval Inspection (PAI) Readiness
  • Documentation Gap Analysis Audit
  • Regulatory Compliance Audit
  • Six Quality System Audit
  • Sponsored Based (Third Party) Audit
  • Post-Inspection Remediation Audit

Facility Designing & Certification (Pharma Plant Set-Up)
Computer Systems Validations (CSV)
Technology Transfer
Qualifications & Validations
Aseptic Processing & Techniques
Microbiological Practices
Process Development
Sterilization Processes
HVAC & Water Systems
Lab Controls & Lab Compliance
Engineering Support
Other-Regulatory-Services

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