LeNova, Inc is known for it's EXCELLENCE in providing robust engineering and technology solutions.

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CGMP Compliance

Regulations and Industries

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CGMPs guide the industry world wide

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The requirements and compliance initiatives are on our side

Knowledge and Practices

  • Applying Codes and Regulations to project execution
  • Quality by Design (QbD) at project initiation
  • Critical Quality Attributes (CQA) & Critical Performance Parameters (CPP) guiding project execution
  • Quality System Inspection Technology (QSIT) for compliance
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System Development Life Cycle (SDLC)

  • Validation Master Plan (VMP) provides project roadmap, resource planning, execution strategy and deliverables
  • Commissioning, Qualification & Validation (CQV) qualify project’s deliverables
  • SDLC secures project deliverables and supports operation for business continuity
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Quality and Compliance are our Foundation

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Projects and Records

  • Compliance assessment and CAPA response to FDA 483 “Inspectional Observations”
  • Design of Experiments (DoE) to assist new drug entity and drug substance development
  • Deviation Management identifying process issues, and improvement opportunities

Quality Management

CGMP training to project and quality control management

All staff members are trained to industry standards

Deliverables meet high quality

90% repeat customers in our portfolio

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Our Compliance and Regulatory Experience

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