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SERVICES

Expertise in Pharmaceutical Development, GMP & Quality Operations and Regulatory Strategies to support efficient approvals.

Pharmaceutical Development

 

  • CRO/CMO related: Project, Process and Study Management.

  • Process Validation and scale up : Clinical and Commercial

  • Analytical Method Development through Validation

GMP Operations

 

  • Set up and Maintenance of GMP Facilities and Operations

  • GMP Supply chain processes : Manual and Automated

  • Lead and Oversee Clinical Development through Commercial Launch

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Quality Operations

 

  • QbD Implementation

  • Audits to API and Drug Product sites

  • PAI/ Inspection readiness and Training 

  • Multiple Agency Inspections: Global readiness

  • Quality Systems: Gap evaluation, End to end solutions

  • Quality Control – Investigations, Assessments and CAPA 

  • Clinical Drug Supply Management and Logistics. 

  • Product Complaints: Set up, Trend Mapping, Report systems

  • Part 11 Compliance: Domain expertise to software companies

  • LIMS, Trackwise, Analytical and Manufacturing/Packaging

  •  Systems: Set up, Maintenance, Troubleshooting and Training

Regulatory Affairs

 

  • Multiple Agency Regulatory Strategy 

    (US, EU, JP, K-FDA, ANVISA, DCGI, Russian MoH)

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