<img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=56875&amp;fmt=gif">
Skip to content

New Product Introduction

 Comprehensive support for launching new products, ensuring operational readiness, seamless tech transfer, supply chain optimization, and quality compliance from development to routine operations.

 

Scope of Services

Facility Operational Readiness

  • Facility, Utilities & Equipment GMP Readiness
  • Handover to Routine Operations

Manufacturing Operational Readiness

  • Documentation Management & Training
  • Engineering Run & GMP Run Readiness

Supply Chain & Logistics

 

  • Supplier & Materials Management
  • Warehouse & Logistics Management

Strategic Planning & Implementation

  • Project, Program & Portfolio Management
  • Transformational Change Management

Digital Systems Deployment

  • Technology Strategy
  • System Implementation & Migration

Technology Transfer Support

  • Planning & Documentation
  • Gap Analysis & Process Validation

Quality & Compliance

  • Quality Systems & Documentation
  • Audit & Inspection Readiness
  • Sample Testing & QC Release

Development Support

  • Analytical Development & Method Qualification
  • Process & Biological Development

Our Product Options

Enterey can tailor a package to meet your needs, here are some examples of products that may help you decide the level of support you require.

Ongoing Support

Comprehensive

Enterey collaborates with you to provide end to end Project, Program, and Portfolio Management Support including:​

  • People​
  • Processes​
  • Tools and Templates
Maintenance

Enterey supports you to the degree that your budget allows for the duration of the effort. We tailor the volume and activities to meet your greatest needs, to include:​

  • Maintaining tools​
  • Driving cadence​
  • Facilitating decision making​
  • Driving continuous improvements

Ad Hoc Support

Planning

A brief engagement to provide:​

  • Kickoff Program​
  • Define Program​
  • Define Program Governance​
  • Develop Integrated Timeline and Dashboards
A La Carte
Select items from the Scope of Services above that you need to achieve your new product introduction goals.

Example Case Studies

paralax

Cell Therapy New Product Introduction

 Our client was introducing and scaling up production of a new cell therapy product in collaboration with a smaller pharmaceutical company. The client's primary goals were to develop a production process from the initial preparation of the cells for clinical trial to the delivery of the cells to the patient, achieve GMP readiness to file the product for an BLA, and establish a hub for clinical trials of this therapy.

Actions Taken

A group of Enterey Consultants provided:​

  • Project management support for creating and managing tools such as an integrated project schedule, project dashboard, risk register, and action items tracker.​
  • Support and oversight of execution of various functional areas: operator training and qualification, supply chain, biologics technical transfer, CAPEX, quality assurance, and manufacturing. ​
  • Requirement workshops with the cross-functional leadership team to ensure milestone delivery.
Results Achieved

With the support and direction of Enterey consultants, our client achieved key project schedule milestones and kept the project on track to achieve GMP readiness, BLA submission readiness, and an operational team to execute the preparation of cells for clinical trials.

people meeting around table birdseye view

Operationalize SUT Facility for GMP Readiness

Our client embarked on constructing and operationalizing an independent Single-Use Technology (SUT) facility designed to facilitate manufacturing operations adhering to clinical and commercial Good Manufacturing Practices (GMP). This facility was constructed with the primary goal of establishing a resilient quality process that excels in Chemistry, Manufacturing, and Controls (CMC) to improve speed to patient by achieving operational efficiency and cost-effectiveness. The identification of cost reduction as a pivotal factor is aimed at enhancing the competitiveness of cell therapies.

Actions Taken

A team of Enterey Consultants provided:​

  • Project management support for creating and managing an integrated project schedule, communication plan, resource management plan, change management, and risk plan for IQ, OQ, and PQ. ​
  • A Project Management Plan to transfer aspects of clinical development and campus build to GMP operations, encompassing supply chain, biologics technical transfer, CAPEX, quality, training, documentation, and vendor management. ​
  • Facilitation of the planning, technical writing, and approval of site SOPs to align with the site quality plan and facility launch.
  • Requirement workshops with the cross-functional leadership team to ensure milestone delivery.​
  • Business processes essential for plant operations integrated into training materials. [Note: playbook]
Results Achieved

With the support and direction of Enterey consultants, our client achieved the building occupancy milestones, successfully conducting technical runs and readiness for GMP campaigns.