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

Established in 1991
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Biopharmaceuticals

Oral Solid Dosage

Over 30 Years of Design and Delivery Knowledge

Areas of Expertise:

Manufacturing Execution Systems (MES)

Process Analytical Technology (PAT)

Continuous Manufacturing Production (CMP)

Oral Solid Dosage unit operation. Oral Solid Dosage unit operation.

Design & Build

  • Understand Client's needs
  • Develop Validation Master Plan (VMP)
  • Obtain User Requirements Specification (URS)
  • Prepare Functional Requirements Specification (FRS)
  • Deliver per Detailed Design Specification (DDS)
  • Execute Commissioning, Qualification, and Validation Protocol (CQV)
  • Complete System Development Lifecycle (SDLC) Documentation for Record
  • Continuous support for business continuity
Oral Solid Dosage Unit Operation. Oral Solid Dosage Unit Operation.
Plantary mixer for Oral Solid Dosage operations.

Planetary Mixer

Custom Design

  • Used to produce medical significant drug
  • Equipment obsolete and unsupported
  • Design specifications conforming to Critical Quality Attributes (CQA)
  • Deliver performance according to Critical Process Parameters (CPP)
  • Prolong manufacturing process lifecycle and avoid drug shortage
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We have Delivered OSD Projects from $25k to $125 Million

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Quality & Risk Management

  • Deviation Management
  • Failure Mode Event Analysis
  • Risk Based Asset Management (RBAM)
  • Remedial Actions and Continuous Improvement

Projects Include

CGMP Compliance

Customized Production Systems

Advanced Technologies

Multi-Products & Multi-Process Facilities

Environmental Monitoring and Controls

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We have completed projects with

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