Our Services
Clinical Services: Nuvalez offers end-to-end support for drug supply in clinical trials, including supply chain management, quality assurance, project management, and trial supplies—ensuring smooth and efficient trial execution.
Commercial Services: Our commercial solutions help pharmaceutical companies navigate regulations and optimize operations, providing the expertise needed to successfully bring products to market and stay competitive.
Clinical Drug Supply Management
Nuvalez Consulting offers a full spectrum of clinical trial supply services, from early planning and forecasting to inventory management, comparator sourcing, IRT setup, and cell and gene therapy logistics. With a focus on precision, compliance, and patient safety, we ensure seamless drug supply coordination, timely delivery, and end-to-end accountability to support the success of your clinical trials.
IRT Management
Nuvalez Consulting provides comprehensive IRT management services to ensure seamless setup, execution, and oversight of Interactive Response Technology systems. We support clients through vendor selection, system design, and UAT, aligning IRT functionality with protocol needs. Our expertise streamlines randomization, drug supply, and subject management, reducing risk and ensuring trial integrity.
Serialization
Nuvalez Consulting provides expert serialization services to ensure product traceability, regulatory compliance, and supply chain safety. We help pharmaceutical companies navigate requirements like the DSCSA and EU-FMD through tailored compliance programs. Our team also enables seamless data exchange with trading partners using efficient methods such as Electronic Data Interchange (EDI).
Sales & Operations
Planning
At Nuvalez, we understand that effective Sales and Operations Planning (S&OP) is the cornerstone of a successful business. S&OP is a dynamic, forward-looking process that connects all key functions within an organization, aligning them towards common goals and objectives. It enables businesses to strike a delicate balance between demand and supply while adapting to changing market conditions.
Audits
Nuvalez Consulting offers comprehensive auditing services, including Internal, External, and Supplier audits to ensure compliance and operational excellence. With certified local auditors across the USA, Europe, India, and China, we eliminate language barriers while identifying improvement opportunities and mitigating risk to support long-term growth.
Validation
Nuvalez Consulting offers expert validation services for pharmaceutical and biotech companies, covering process and computer systems validation to ensure regulatory compliance and product quality. Our solutions enhance operational efficiency and strengthen quality assurance.
Whether you're advancing clinical development, streamlining manufacturing, or launching pharmaceutical products, Nuvalez Consulting is your trusted partner. We offer expert guidance and tailored strategies to optimize drug supply, logistics, and clinical trials—empowering you to make informed decisions and drive your operations forward with confidence.
Launch Management
Nuvalez Consulting supports pharmaceutical companies in navigating the complexities of product launch with strategic planning, precise execution, and expert guidance. We partner with clients to craft tailored launch strategies that boost product visibility and ensure a strong market entry, laying the groundwork for lasting commercial success.
Logistics Management
Nuvalez Consulting delivers expert Logistics Management tailored to the pharmaceutical industry, with a strong focus on regulatory compliance and shipment precision. We handle the end-to-end movement of drug substances and products, using innovative strategies for route planning, temperature-sensitive handling, and packaging. Our established partnerships with trusted carriers ensure secure, timely deliveries, while our team takes full ownership of the logistics process—freeing clients to focus on advancing their research and development goals.
Orphan Drug Supply Management
Nuvalez Consulting specializes in managing the unique challenges of Orphan Drugs, which are typically low volume, high cost, and critical in demand. We help pharmaceutical companies identify and manage the right supply base to ensure reliable, efficient supply despite small or uncertain demand.
Due Diligence
At Nuvalez Consulting we offer a comprehensive Due Diligence service on our website, catering to both Asset and Site Due Diligence needs. With a wealth of experience working alongside prominent companies such as Astra Zeneca, MSD, and J&J, our team is well-equipped to guide you through the intricate process of assessing potential investments. Our services go beyond mere expansion, focusing on seamless integration into your existing operational environment. Whether you're an established enterprise or a budding investor, Nuvalez Consulting provides the expertise required to make informed and strategic decisions in the due diligence arena.
Recognition
Northeast Business Excellence Awards 2023
Winning the Northeast Business Excellence Award for SME of the Year highlights Nuvalez’s unwavering commitment to excellence, innovation, and leadership in pharmaceutical consulting. This prestigious recognition celebrates our strategic vision, exceptional client service, and meaningful contributions to the Northeast business community. It marks both a proud achievement and a powerful motivator as we continue to drive innovation and shape the future of the industry.