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

Established in 1991

CGMP Compliance

Regulations and Industries

CGMPs guide the industry world wide

Training tool for compliance and self-assessment

The requirements and compliance initiatives are on our side

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

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

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

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