Our services.

  • Process Engineering

    Comprehensive manufacturing process development from bench-scale through commercial production. Specializing in technology transfer execution, process optimization, and equipment selection.

  • CMC Strategic Support

    Chemistry, Manufacturing & Controls expertise spanning regulatory submissions, GMP compliance, and quality management systems. Direct FDA interaction experience with BLA submissions, Type C meetings, and IND-enabling documentation.

  • Data Engineering & Insights

    Advanced analytics solutions leveraging Python and Power BI to transform manufacturing data into executive dashboards, real-time batch tracking, and strategic decision-making tools for early phase through commercial programs.

Contact Us

Process Engineering

  • Technology transfer execution

  • Process development & optimization

  • Facility fit & equipment selection

  • Single-use technology implementation

  • Upstream & downstream unit operations

  • Process flow diagrams & P&IDs

  • Manufacturing readiness planning

  • Protocol development & execution

  • Process validation strategies

  • Scalability assessments

CMC Strategic Support

  • Regulatory filing support (BLA, IND)

  • FDA interaction & Type C meetings

  • GMP compliance & quality systems

  • Batch record review & approval

  • Deviation investigations & CAPA

  • Change control management

  • Risk assessment & mitigation

  • Manufacturing science & technology

  • Process validation campaign design

  • CDMO management & oversight

Data Engineering & Insights

  • Manufacturing dashboard development

  • Python-based data analysis

  • Power BI visualization & reporting

  • Real-time batch tracking systems

  • Quality metrics & KPI monitoring

  • Campaign readiness tracking

  • Database design & management

  • Process data analytics

  • Executive reporting solutions

  • Automation & workflow optimization

Technical Operations

  • GMP operations oversight

  • Person-in-plant (PIP) services

  • Cross-functional team leadership

  • Supply chain & logistics coordination

  • SOW negotiation & budget tracking

  • Manufacturing troubleshooting

  • Technical documentation

  • Project management

  • Vendor qualification & management

  • Commercial scale-up planning

Laboratory & Analytical

  • Method development & validation

  • HPLC & FPLC analysis

  • Protein expression & purification

  • High-throughput screening

  • Analytical method qualification

  • Quality control testing

  • Assay development

  • Laboratory setup & management

  • Bench-scale process development

  • Platform development