In the fast paced world of pharmaceuticals and biotechnology, only a skillful and results-oriented approach will succeed in the international arena.

At White Owl Global Services Ltd, we consult with our clients and focus our energy and resources to provide professional and dependable services that exceed your unique requirements and needs.

To provide flexible assistance, White Owl Global Services Ltd offers a full range of services that can be tailored to accelerate your development, packaging and commercial processes:

Strategic CMC Consulting Services

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API:

• Small & large molecule development
• Scale-up and commercial production
• Stability design

Drug Product:

• Phase 1 through Phase III product development across various drug dosage and biologic forms - including:
  
  • Solid oral (tablets, capsules)
    
  • Semi solid
    
  • Liquid (including injectibles)
    
  • Lyophilization
    
• Process Scale-Up
  
• Technical Transfers
• Analytical method development and validation
  
• Clinical packaging
• Stability design

Validation:

• Comprehensive Master Validation Plan
  
• Design and execution of Process and Packaging Validation studies

Quality / Regulatory Services:

• Comprehensive cGMP compliance assessments / audits with full report
• Technical writing and reviews of comprehensive list of required Standard Operating Procedures (including Corrective
• Action/Preventative Action, Change Controls, Quality Investigations), Master Production and Packaging Records
• Reviews of executed documents
• Trending analysis
• Preparation of Chemistry and Manufacturing Controls (CMC) section for US/Canada/EU regulatory agencies, including:
  • End of Phase II reports for FDA
  • DMF
  • IND/CTA/IMPD
  • NDA/NDS
  • ANDA/ANDS

Project Management:

• Identify and qualify contract laboratory / manufacturing site based upon your specific needs
• Procure quotations
• Manage interface between contractor and your organization
• Provide risk analysis and mitigation strategies

Commercialization:

• Supply chain management of commercial supply of materials