Below are examples of projects Verta Life Sciences have completed for clients.
Formulation Development Case Study – Topical
- Develop and dissolution method that could support a bioequivalence waiver for alternate dose strengths in accordance with FDA and EMA guidance for the demonstration of bioequivalence.
- Quickly implementing measures to mitigate loss in sales and establish alternative supply routes.
- Simplifying a supply chain to drive cost reductions.
- North African Distribution Optimization.
- Lean Supply Chain.
- The implementation of a Supply Chain Sales and Operations Planning (S&OP) process.
- Establishing a global program to rationalize the manufacturing network of a major pharmaceutical company.
- Rationalizing a Contract Manufacturing Organisation (CMO) network to consolidate activity, reduce cost, increase quality and respond to changes in market.
- Establish a manufacturing strategy to provide sufficient manufacturing capacity to meet projected demands at key stages of product development, and in preparation for launch.
- Identifying suitable manufacturing partners to manufacture clinical trials materials and prepare for launch.
- Implementing a robust technology transfer process to ensure technical transfers occur on time with no disruption to supply.
Improving Manufacturing and Business Processes
- The volume of samples to be tested by the micro lab was forecasted to increase by 30% in the next 12 months.
- How could the lab throughput be improved to allow absorption of the extra work without any additional headcount?
- Providing an external analysis and recommendations on the current status and potential gains of your Lean and Six Sigma deployment,.
- Leading workshops and training events, and providing ongoing implementation and project support
- Developing a structured approach to implementing the cultural and people changes necessary to ensure that your business improvements endure in time
- Working closely with your team as well as your customers and suppliers to build the “Lean Supply Chain”.
- Selection of appropriate technology and companies to improve cleints current Active Pharmaceutical Ingredients (API) manufacturing process to significantly improve cost of goods (COGs).
- Establishing a Oral Solid Dose (OSD) manufacturing technology and process platform.
- Review of a client’s current packaging specifications and transit procedures to reduce damage during transit.
- Resolution of stability failures by the selection apropiate container/closure system, and packaging procedures.
Driving Quality and Compliance
- Implementing a risk based global audit program for a multinational pharmaceutical manufacturer enabling focused and consistent evaluation of their compliance risks
- Creating and executing a Validation Master Plan to ensure a leading national health care organizations existing laboratory information system (LIS) was FDA compliant including 21 CFR Part 11.
Establishing Advanced Manufacturing Capability
- Developing a capacity plan that minimizes and defers significant capital expenditure.
- Helping a client understand their long term space and functional requirements, analyzing options to meet its facility needs and recommending the way forward.
- Creating a new manufacturing facility for solid dosage and liquid products that leverages innovative technology to allow efficient production of short runs of multiple products.
- Specifying and procuring suitable manufacturing equipment to manufacture phase III clinical trails materials for a drug loaded device.
- Establish the program of work required to start-up operations in the new manufacturing facility and gain regulatory approval as quickly as possible.
- Identifying potential purchasers for manufacturing sites no longer required and negotiate sales to deliver win/win for the selling and buying organizations.
Making Change Happen
- Helping a major pharmaceutical company ensure continued compliance in an environment of increasingly stringent regulatory requirements.
- Rapidly installing and start-up a technically challenging robotic technology project to enable a step change in business performance.
- Review available Due Diligence data of a product in phase IIb of a development program and recommend if the acquisitions should progress from a manufacturing and supply perspective.
- Integration of the manufacturing and supply operations following the acquisitions of a specialist virtual pharmaceutical company for $1.6 billion by a larger pharmaceutical company.
- Helping a small pharmaceutical company purchase a legacy product from a large pharmaceutical company.