Below are examples of projects Verta Life Sciences have completed for clients.

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Product Development

  • Formulation Development Case Study – Solid Dose Formulation Development #1 v2
    • Formulation and method development for a fixed dose combination product that was safe, effective and stable for the treatment of an unmet medical need.
  • Formulation Development Case Study – Topical Formulation Development #2 v2
    • Development of a safe, effective and stable formulation for a topical drug product for the treatment of an unmet medial need.
  • Formulation Development Case Study – Sterile Powder Formulation Development #3 v2
    • Development and optimization of a sterile powder filling process to meet current Quality by Design as well as ICH and FDA requirements.
  • Formulation Development Case Study – Solid Dose Formulation Development #4 v2
    • Optimization of an existing process to develop a common granulation that could be sued for three additional dosage strengths and accelerating the CMC submission process.

NPI and Commercialization

  • New Product Introduction Case Study  New Product introductions v2
    • Identifying suitable manufacturing partners to manufacture clinical trial materials and prepare for product launch.

Manufacturing Process

  • Manufacturing Strategy Case Study  Manufacturing strategy v2
    • Establish a manufacturing strategy to provide sufficient manufacturing capacity to meet project demands at key stages of product development and in preparation for launch.
  • Process Improvement and Process Technology Case Study  Process Improvement and Process technology v2
    • Establishing an oral solid dose manufacturing technology and process platform.
  • Equipment Selection, Procurement, Installation and Qualification Case Study  equipment selection-qualification v2
    • Specifying and procuring suitable manufacturing equipment to manufacture phase III clinical trial materials for a drug loaded device.
  • Manufacturing Strategy II Case Study
    • A strategic review identifying manufacturing and supply opportunities that would allow a company to capitalize on their strengths and risks that might restrict their ability to maximize shareholder value.

Advanced Manufacturing Capability

  • Lean Six Sigma Case Study
    • Providing an external analysis and recommendations on the current status and potential gains of your lean and Six Sigma deployment.
  • Facility Strategy and Creation Case Study  Facility StrategyA v2
    • Creating a new manufacturing facility for solid dose and liquid products that leverages innovative technology to allow efficient production of short runs and multiple products.
  • New Manufacturing Site Start-Up Case Study  New Manufacturing Site Start -Ups v2
    • Establish a program of work required to start-up operations in a new manufacturing facility and gain regulatory approval as quickly as possible.

Quality and Regulatory Compliance

  • Analytical Development Case Study  analytical development v2
    • Develop a dissolution method that could support a bioequivalence waiver for alternate dose strengths in accordance with FDA and EMA guidance for the demonstration of bioequivalence.
  • Lean Microbiology Laboratory Case Study  Verta Case study Lean Microbiology Laboratory v2
    • Develop a lab throughput process that allows the absorption of a 30% workload increase without increasing headcount.
  • Implementation of a risk based global audit program Case Study  risk based global audit program v2
    • Implementing a risk based global audit program for a multinational pharmaceutical manufacture while enabling focused and consistent evaluation of their compliance risks.
  • IT Strategy and CFR21 Part 11 Compliance Case Study  computer system IT Strategy & Computer system GXP v2
    • Creating and executing a Validation Master Plant to ensure a leading national health care organizations existing laboratory information system (LIS) is FDA compliant including 21 CFR part 11.
  • Change Management Case Study – Quality Focus  Change Management v2
    • Helping a major pharmaceutical company ensure continued compliance in an environment of increasingly stringent regulatory requirements.
  • CMC Regulatory Case Study CMC Regulatory v2
    • CMC Post-Approval change of a controlled release tablet, involving changes to the manufacturing site, batch size and process.
  • Computer System Validation Case Study  computer system validation v2
    • An expedited and technically challenging robotic technology installation.
  • Stability Support Case Study  Stability Support v2
    • Stability program design for a new product that would meet regulatory requirements in multiple climate zones.

Manufacturing Supply Chain

  • Supply Chain Consulting Services Case Study  Supply Chain Consulting Services v2
    • Quickly implementing measures to mitigate loss in sales and establish alternative supply routes.
  • Logistics Service Provider Selection and Support Case Study  Logistices Service Provider selection and support v2
    • Phase IIb product that required the development of a low-cost supply chain using a mixture of in-house and external contract manufacturers.

Project and Program Management

  • Technology Transfer Case Study  technology transfer v2
    • Implementing a robust technology transfer process to ensure technical transfer occur on time with no disruption to supply.
  • Packaging Technology Case Study  Packaging Technology v2
    • Resolution of stability failures by the selecting appropriate container/closure systems and packaging procedures.
  • Capacity Planning Case Study  Capacity Planning v2
    • Development of a capacity plan that minimizes and defers significant capital expenditure.
  • Project Management Case Study  Project Management v2
    • Rapidly installing and start-up a technically challenging robotic technology project to ensure a step change in business performance.
  • Artwork Case Study  Artwork v2
    • EMA artwork submission required a bottle label change for multiple strengths, incorporating three (3) languages and braille.

Mergers and Acquisitions

  • Site Sale Case Study  Site Sale v2
    • Identifying potential purchasers for manufacturing sites no longer required and negotiating the site sale to deliver a wine/wine for the selling and buying organizations.
  • Mergers and Acquisitions Case Study  Mergers & Acquisitions v2
    • Review available Due Diligence data of a product in phase IIb of a development program and recommend if the acquisition should progress from a manufacturing and supply perspective.
  • Mergers and Acquisitions II Case Study  mergers & acquisitions II v2
    • Assisting a small pharmaceutical company purchase a legacy product from a large pharmaceutical company.