Deep Domain Expertise In Every Stage Of The Drug Development Lifecycle & The Patient Journey.
We Are You
Our experts come from small and large biopharmaceuticals, many with more than two decades of experience as bench scientists, commercial launch leaders, CMC managers, program, and data managers and so much more! We understand what works for your specific business and the time pressures to complete research, prepare for an audit and launch your first or tenth product.
Even though there are best practices, we tailor each assignment to your unique needs and strive to create better practices and ways to optimize your processes and always keep you in a state of control.
We Support You Through All Aspects of the Entire Lifecycle.
Our team of experts can help with research data, processes, and applications, to seamlessly move you through development with tech transfer, scale-up and compliance requirements for US, EMEA and across the world. Establishing new QMS systems and processes is our forte and our experts work with leading tools such as KNEAT to automate those processes. Leave it to our teams to create your product launch plan and help see you through to commercialization. Our business analysts can help with the myriad of new data and applications, including an enterprise data lake or warehouse.
From exploratory biology to regulatory approval, we optimize processes and technology so our clients can focus on the science and can effectively and efficiently develop new therapies.
Today’s research approaches are impacted by data volume and complexity, new and emerging technology, and the need to share information across the enterprise. And the dynamic nature of the research process, the regulated nature of the clinical process, and their interplay are critical to successful R&D initiatives.
We can strategize, plan, and implement Scientific Informatics programs.
Our business analysts and program managers can help you assess, select, and implement lab systems such as LIMS, ELN, Assay Management and Registration systems.
Our team of experts can help you with all aspects of research data including data migration, integration, governance and ontology and semantic data management.
Clinical & Product Development
As you move from research to clinical trials, your processes must incorporate data and process compliance in their design. Our business analysts can help gather requirements for applications, data, and processes. Our expert team of quality analysts and auditors can help to ensure that you are compliant from the start. As you move from clinical trials to commercialization, our CMC experts can guide you in tech transfer, scaleup activities, and help you manage CRO, CMOs and other vendors to ensure that you are always in a state of control. We cover all aspects of manufacturing, including machine automation and validation, vision inspection systems, purity and batch record compliance activities, fill and finish advisory and implementation as well as your full supply chain. We can also assist, or manage for you, analytic development activities.
We can provide CMC advisory including quality control and assurance as well as leadership and vendor management and strategies.
Our experts can provide strategy and advisory for tech transfer and scaleup including selecting, managing, and auditing CMOs.
We provide business analysis and program management as well as process design for a host of clinical applications.
Our team can work with your, or manage completely, your eTMF data, applications, and processes.
Companies preparing for their first go to market drug need to develop new front-office capabilities for product launches, new selling models, and product acquisition. Mature companies that expand into new markets require planning and execution to integrate new therapies with existing commercial footprints.
We help companies understand this business evolution from both a maturity and marketplace perspective. And we help solve the difficult technical challenges this creates. We define right-sized strategies and solutions with a keen focus on the full scope of commercial business requirements.
We can help you effectively analyze and improve the commercial viability of your products through commercial launch planning and strategy programs.
Our team of experts can help you select commercial processes and tools for every aspect of commercialization, including enterprise data lakes and warehouses.
We can help you to enable your field force with guidance in CRM, Market Access, Digital Enablement and Territory and Roster processes and toolsets.
We cover all aspects of commercial manufacturing from CMC activities to packaging and serialization as well as 3PL and distributor integration. We are unique in that we can help you from the factory floor with vision inspection, automation, and validation to the board room with strategic planning and road-mapping – and everything in between.
We define right-sized strategies and solutions with a keen focus on the full scope of commercial business requirements.
Project and Program Management
While there are industry standards for project and program management, each company has a unique culture and is at a different point in their product development journey. Our experienced team works with you to effectively manage and control your project, programs and portfolios. Verista has a very strong GXP quality culture and experience that ensures that your projects are always in state of control. We ensure communications are clear and relevant, change is controlled, issues and risks are managed, quality is assured, and project success is realized.
We provide methodology and best practices material and training for all types of project management: waterfall, agile and hybrid. Our methodologies also include project health, Program Management Office (PMO) and Application Portfolio Optimization (APO).
For new startup companies, getting your application portfolio right can be challenging. Regulatory requirements add complexity and risk to this effort. We have worked with many new startups to create an application portfolio and roadmap with the right processes and procedures for GXP compliance.
For larger organizations, we can provide resources as needed or through a Managed Services offering, allowing for flexibility during these trying times.
Our team of seasoned experts can design and implement a robust and effective Program Management Office that respects your culture yet ensures effective project management and implementations.
Information Management & Analytics
Drug and product development continues to change and move at a faster pace than ever. Critical decisions need to be made nimbly and with data that can be trusted. Our team understands compliance requirements for data integrity, and we work with you to go beyond this to ensure that data has value throughout the product lifecycle.
Our team provides a full suite of data services from enterprise data and governance strategy all the way to interfacing data with software and hardware. We specialize in GXP data integrity as well as specific business solutions such as commercial, research and clinical data.
We work with you to provide a right-sized data strategy that is value based, flexible and ensures compliance to the laws and regulations throughout the product life cycle.
Our team understands how to interface data from all types of hardware and software to the entire organization. We have business expertise throughout the lifecycle including manufacturing, research, development, commercial and clinical data.
Business Analysis & Architecture
One of the biggest reasons for project failures is the lack of stakeholder involvement and communication. Organization Change Management (OCM) provides the framework for ensuring project success through effective communication, training, and stakeholder involvement. Our experts in OCM can help you manage change from small projects to the largest programs.
Our team provides subject matter experts that can also guide you in business modeling, process engineering and requirements gathering and documentation – with GXP and subject matter expertise to ensure success now and in the future.
We work with you to manage change, small and large. Our experts help to ensure that the organization is ready for the changes such as Phase 3 trials and approval, commercialization, tech transfer and scale-up.
Our team can work with you to model your current and future state business processes. We can take the gap between current and future state and engineer new processes that adhere to compliance while ensuring business value.
Our subject matter experts can gather and document requirements for new or updated processes and software solutions.