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