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Accelerate Operation Performance
Life science companies come to Navigator when they find their ability to grow and/or adapt is being limited by their current business processes and systems. Navigator helps accelerate operational performance through digital transformation in life sciences software, so our clients can drive innovation, grow their business, become a leader in the industry, and increase market share.
“Overall, with the help of Navigator consultants, we’ve reduced our work probably on average 30% within the finance department alone.”
- Leah Peene, Business Analyst at CeloNova BioSciences
A Tier One Software Platform Is Needed To Meet Regulatory Compliance Requirements
Life sciences companies are at the center of today’s healthcare and medical global supply chain disruption. They are navigating a dramatic increase in demand, rapidly changing expectations from global partnerships, and increasing competition from start-ups looking to capture industry market share.
They manage a complex and globally-based supply chain on a daily basis. This requires companies in the life sciences to have real-time visibility; going beyond price and availability to include the necessary quality and regulatory aspects of materials.
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Ready-To-Validate Cloud Platform
Navigator Business Solutions offers a unique digital solution that meets the requirements of your life sciences company regardless of business life-cycle stage; from R&D start-ups, early-stage clinical trials, and scaling to full commercialization. Life science solutions combine a ready-to-validate (Validation Services) cloud platform with years of life sciences industry experience to deliver a fully 21 CFR Part 11 compliant solution.
“With a validated and scalable ERP system, the company is advancing its vision to build the world’s largest cell and gene therapy manufacturing and testing facility and enable the rapid development and delivery of groundbreaking treatments for patients,” said Peter Carbone, COO, Center for Breakthrough Medicines
The solutions are built on the fully integrated SAP Cloud ERP, enhanced with additional specific functionalities that help life sciences organizations optimize their supply chain, comply with business and industry requirements, improve forecast accuracy, drive operational efficiency while meeting Good Manufacturing Practices (GMP) including DSCSA compliance support.
How do quarterly ERP software updates impact FDA Validation [Blog]
Prepare for growth with data business solutions that scale with you, stay compliant with built-in approvals & process flows, and improve quality control with pre-design quality levels.
LIFE SCIENCE SUCCESS STORIES
“I think it speaks well to the knowledge and the experience that Navigator brings to the table, as well as being able to quickly migrate in a fast-paced environment.”
Marc Garofani
CFO
BIODERM, INC.
LIFE SCIENCE SUCCESS STORIES
“With a validated and scalable ERP system, the company is advancing its vision to build the world’s largest cell and gene therapy manufacturing and testing facility and enable the rapid development and delivery of groundbreaking treatments for patients,”
Peter Carbone
COO
Center for Breakthrough Medicines
LIFE SCIENCE SUCCESS STORIES
"We can run reports upside down, inside out, any way you want it, you can get a report to tell you what the numbers look like. We now have all the information in one system – from CRM to the end of finance, we have tracking on everything we need."
Leah Peene
BUSINESS ANALYST
CELONOVA BIOSCIENCES
LIFE SCIENCE SUCCESS STORIES
“We told Navigator that we wanted their out-of-the-box, best practices for pharmaceutical companies"
Scott Harris
VP of TriRx
You may be currently experiencing trouble with:
- getting approvals & maintaining FDA compliance
- closely monitoring expense management & full visibility over expenses related to projects and trials
- meeting demand & accurately forecasting sales with reliable data
- growing into a full ERP; taking on sales, manufacturing, production planning, quality management, & more when the commercializing process begins
- ERP DELIVERED BY NAVIGATOR
- Services
- RAPID IMPLEMENTATIONS
- SCALABILITY
- CONTROLS
- PROJECT TRACKING AND LIFE SCIENCES ANALYTICS
- GLOBAL FINANCE
- COMMERCIALIZATION
SAP ERP DELIVERED BY NAVIGATOR
We at Navigator believe that our client's success depends upon understanding their Life Sciences focus well enough to help them achieve their goals.
We know your research and science are just as important as the business side of your organization. We're committed to helping you solve business challenges and create opportunities in the life science industry through technology. We're here because our clients need us; they trust us to help them grow their business. The key to building this understanding is knowing the life sciences industry and the detailed process and business issues related to each segment, and how an organization can use technology to keep up with the fast-paced nature of the industry.
Leveraging cloud ERP, Navigator Business Solutions helps growing Life Sciences companies access better visibility into their business, position themselves for success, and help manage and control the costs involved in research, trials, and commercialization. We know and have been building on top of the industry-leading SAP solutions for years now to support every business phase - from start-up and early research, into trials, and through commercialization, M&A, or an IPO.
Leveraging the SAP ERP Solution and specially developed industry extensions, we can work with you to implement technology that fits your organizational needs where you are and provide a robust platform for your company's continued growth.
Whether a pharmaceutical, biotech, medical device, or contract manufacturer, the demands of life sciences companies change as quickly as science. This type of dynamic industry requires an agile and scalable ERP solution, like SAP ERP. The correct ERP solution will help manage common challenges, track and trace requirements, provide real-time visibility into expenses and revenue, and provide tools for consolidation and reporting all within a validation-ready system.
Navigator's SAP ERP life science solution offers the best of SAP’s functionality, knowledgeably configured and implemented to meet the needs of life sciences organizations where they are today and scale with them into future growth. The ERP solution that fits your company's needs will allow your whole organization to focus on science, growth, efficiency, visibility, and compliance.
Services
Navigator brings more than ten years of experience delivering services and solutions to improve the way you work with flexibility & scalability to bolster the efficiency of your entire enterprise no matter the size
Our services, innovative solutions, and direct approach help you support:
- Complex supply-chain visibility; Better Track & Trace Materials & Transactions
- Compliance with FDA: CFR 21 Part 11
- Global Project Management, Collaboration & Project Cost Functionality
- Out-Of-The-Box Regulatory Compliance and Quality Control Functionality
- CAPA (Corrective Action Preventive Action)
- Recall Management
- Electronic Signatures
- Supplier & Internal Quality Audits
- Plant Maintenance
- Multi-Location Support: country, company, language, currency, taxes, GAAP, and industry regulations
- Designed for GDPR Compliance
All services are delivered through a thoroughly tested digital implementation process provided on a fixed scope and fixed price, which minimizes risk and maximizes the opportunity for success.
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RAPID IMPLEMENTATIONS
We have done numerous implementations of SAP ERP for life sciences companies and bring leading practices based on those past implementations as part of our life sciences packaged solution. With this expertise, we are able to get companies up and operating on the correct enterprise resource planning (ERP) system sooner and at lower costs.
SCALABILITY
SAP ERP, a cloud-based enterprise resource planning system, provides a scalable solution that will grow with the organization as it progresses toward commercialization and beyond.
As you grow, life sciences manufacturing efficiencies are critical for upstream and downstream operational success.
CONTROLS
Auditable change controls, configurable approval workflows, and user roles allow for the segregation of duties with strong internal financial and change controls providing for SOX compliance promoting investor confidence and Track and Trace as well as 21CFR part 11 requirements. Recommended tools and processes will improve the speed of your financial close and provide data transparently throughout the organization.
PROJECT TRACKING AND LIFE SCIENCES ANALYTICS
SAP ERP solutions provide project tracking functionality, including time and expense entry and budgeting. It also helps track research and development and capital costs across your organization.
Make use of your data with life sciences analytics capabilities that help improve outcomes throughout your pipeline.
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GLOBAL FINANCE
General ledger, payables, fixed assets, and cash flow are the engines that drive most transactions. The SAP ERP solution is designed from the ground up to support multiple entities, multiple locations, multiple currencies, and multiple languages with robust consolidation reporting features. With built-in system tools to help budget, plan, and forecast financials, inventory, and supply chain.
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COMMERCIALIZATION
When the time comes and the commercial model has been developed for your product/service, we can optimize it to support your interactions with contract manufacturing organizations (CMO), third-party logistics providers, and procurement vendors. There is no need to implement another toolset to support future growth. Our supply chain professionals can help develop additional new processes to support your expanding business (through natural growth or acquisition). The SAP ERP solution provides a future-proof design to support inventory, sales order processes, R&D, and additional commercial operations down the road.