NGT Cares.NGT BioPharma Consultants, a multidisciplinary team of industry experts and professionals, provide innovative and customized solutions to all sectors of the global biopharmaceutical industry. Our highly experienced consultants leverage a range of strategies and processes to deliver transformative results.

Small molecule drugs and biologics research, development and manufacturing to attain regulatory approvals and achieve rapid market entry.

Small molecule drugs and biologics research, development and manufacturing to attain regulatory approvals and achieve rapid market entry.

Services

Discovery Research and Drug Development
Discovery Research and Drug Development
  • Target validation with human confidence-in-rationale
  • Predictive model-based drug discovery
  • Accelerating lead generation to candidate selection
  • Development of biological drugs, cells and NCE/NBE drug targets
  • Pre-clinical to commercial organic synthesis, formulation development
  • API, drug product and analytical process development
  • QbD, PAT and clinical manufacturing platforms
Manufacturing Technologies and Processes
Manufacturing Technologies and Processes
  • Pharma 4.0 ‘concept-to-application’ strategies
  • Custom interfaces for in-line monitor and control sensor
  • Continuous manufacturing platforms and processes
  • Modular and ‘podular’ manufacturing facility designs
  • Robust technology transfer best practices
  • Analytical sciences and process analytical technologies (PAT)
  • Process-based analytics
Regulatory Sciences and Submissions
Regulatory Sciences and Submissions
  • Evaluation and resolution of complex CMC and clinical compliance issues
  • US, EU and Asia clinical trial protocol design
  • Document preparation, review and e-submissions
  • Regulatory agency correspondence using secure communication channels
  • Audits and reviews for pre-approval inspection readiness and post-approval LCM
Digital Innovation and Data Analytics
Digital Innovation and Data Analytics
  • Digital and data strategy creation and implementation
  • Organizational efficiency through digital technologies
  • ‘Critical workflow’ block-chain technologies
  • Predictive to prescriptive analytics
  • MES and digital manufacturing strategies
  • Artificial Intelligence (AI) and machine learning
Comprehensive and Multi-Disciplinary Due Diligence
Comprehensive and Multi-Disciplinary Due Diligence
  • Risk assessments to mitigate clinical, CMC and regulatory issues
  • Valuations for strategic mergers and acquisitions
  • Commercial potential of new NCE and NBE drug candidates
  • Clinical and commercial evaluation of manufacturing approaches and processes
  • Regulatory documentation and quality systems
Business Development
Business Development
  • Landscaping, open innovation and investment strategies
  • Market and asset analyses
  • Strategic collaboration and alliances
  • Access to R&D ecosystem, including incubator firms
  • Internal and multi-party stakeholder alignment
  • Talent acquisition and organizational architecture