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SERIALIZATION
& VALIDATION
SERIALIZATION
Nuvalez Consulting offers comprehensive serialization services that form a crucial foundation of effective pharmaceutical supply chain management. Serialization is more than just a requirement; it's a fundamental aspect of ensuring product traceability, regulatory compliance, and the utmost safety across the supply chain. Our expert team specializes in guiding pharmaceutical companies through the intricate landscape of serialization, providing tailored programs to guarantee full compliance with regulatory mandates, such as the Drug Supply Chain Security Act (DSCSA) and Europe's Falsified Medicines Directive (EU-FMD).
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We understand the significance of seamless information exchange in serialization, especially when it comes to content-to-container relationships with trading partners. To facilitate this, we utilize efficient methods like Electronic Data Interchange (EDI) for sharing serialization information.
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At Nuvalez, we offer more than just compliance – we offer efficiency, adaptability, and forward-thinking solutions to meet the evolving needs of the pharmaceutical industry. Serialization is not just a regulatory necessity; it's a strategic opportunity, and we're here to guide your pharmaceutical company through the process.
VALIDATION
Nuvalez Consulting specializes in validation consulting, providing pharmaceutical and biotech firms with expert support to meet rigorous industry requirements. Our seasoned team offers a broad spectrum of services, encompassing everything from process validation to computer systems validation, ensuring adherence to regulatory mandates and product quality. We are committed to enhancing operational efficiency and reinforcing quality assurance, delivering robust and effective validation solutions for our clients.
We provide comprehensive periodic revalidation
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We specialize in a wide range of validation activities, including:
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Risk-based validation approach
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Quality Management System (QMS) analysis
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Validation plan creation
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Computer System Validation (CSV)
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GAMP®5 solutions and V-model
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SOP creation and training management
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Data integrity consultation
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Audit management and support
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Cloud solutions validation (IaaS, PaaS, SaaS)
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Process validation
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Equipment validation
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Analytical method validation
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Regulatory compliance (GMP, FDA)
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Documentation and record-keeping
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Training and qualification
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Periodic revalidation
Standards & Regulations
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ISO 9001: International standard for quality management systems.
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GAMP 5: Good Automated Manufacturing Practice guidelines for pharmaceutical industries.
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EU GMP Annex 11: European Union's guidelines on computerized systems.
CLINICAL TRIAL DRUG
SUPPLY MANAGEMENT
We understand that precision and attention to detail are paramount in the clinical trial drug supply process. Leveraging our expertise and innovative strategies, we offer a comprehensive range of services to ensure the seamless coordination and timely delivery of trial drugs. By partnering with us, our clients can conduct trials with maximum efficiency and confidence, ultimately advancing medical breakthroughs.
Planning & Forecast Management
At Nuvalez Consulting, we recognize the significance of early project planning. Our involvement begins by providing robust forecasting and demand planning for trial drugs, placebos, and trial supplies. We create a tailored supply chain strategy to optimize kit configuration and minimize wastage. Working closely with sponsors, drug supply vendors, and project teams, we develop a clinical supply management plan that guarantees uninterrupted supply, thus ensuring the success of your clinical trial.
Comparator Sourcing
Our global network of sourcing specialists is dedicated to sourcing the right products and documents to support trial submissions. Whether through direct manufacturer contracts or purchases in the open market, we ensure access to the necessary materials for successful clinical trials. Comparator sourcing is a critical element of our services, and we are committed to providing the highest quality support to our clients.
Inventory Management
Nuvalez Consulting offers a comprehensive suite of services in inventory management and distribution. We maintain our own depot locations and collaborate with an extensive third-party depot partner network. This enables us to provide top-tier warehousing and global logistics services, adhering to the highest operational standards in the industry. We also offer expert guidance on selecting the most suitable couriers in each region, considering in-country regulations and product characteristics to ensure smooth and compliant distribution.
Interactive Response Technology (IRT)
Nuvalez Consulting ensures that the chosen IRT performs optimally to deliver the best trial outcomes. We determine the optimal supply and resupply parameters, set expiry date triggers, and collaborate closely to finalize the User Requirements Specification (URS). With a focus on excellence and efficiency, our IRT services are integral to the success of clinical trial drug supply management.
Cell and Gene Therapy
Nuvalez is your trusted partner when it comes to navigating the intricate world of live cells and tissue in the field of cellular and gene therapy. We understand the critical importance of precise tracking, meticulously monitoring the chain of custody, condition, and identity on a case-by-case basis. In our approach, the patient always remains at the forefront of our focus. We prioritize their well-being and the success of your business by implementing rigorous risk mitigation planning.
Accountability
At Nuvalez, we take responsibility for all investigational products (IP) as your study concludes, overseeing the proper return and disposal of unused products and ensuring accurate supply record reconciliation.
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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.
Our Approach
Cross-Functional Collaboration
We facilitate seamless collaboration among various departments, including sales, operations, marketing, finance, and more. This ensures that all functions are aligned and working cohesively towards a shared vision.
Integrated Technology
We harness the power of integrated technology solutions to streamline the S&OP process. This includes the use of advanced software and analytics tools to facilitate data-driven decision-making.
Demand Forecasting
Accurate demand forecasting is crucial for effective S&OP. We leverage cutting-edge tools and methodologies to analyze historical data, market trends, and other factors to provide reliable demand forecasts.
Scenario Planning
We help you prepare for various scenarios, ensuring that your business can adapt to unexpected changes, whether they are market fluctuations or supply chain disruptions.
Supply Planning
We optimize your supply chain, making sure that your operations are flexible and responsive to changes in demand. This involves capacity planning, production scheduling, and inventory management.
Balanced Decision-Making
With a comprehensive view of your business's performance, we guide you in making balanced decisions that take into account all aspects of your operations.
QUALITY
ASSURANCE
In the fast-paced and competitive landscape of today's business world, maintaining consistent quality in products and processes is non-negotiable. The key to building trust and confidence among customers and stakeholders lies in having a robust Quality Management System (QMS) in place. Nuvalez Consulting understands this fundamental principle and offers a comprehensive Quality Assurance consultancy service that empowers organizations to reach new heights of excellence.
Our Approach
We recognize that some clients may be at different stages of their journey. For pre-clinical and start-up clients, we offer complete lean and phase-appropriate Quality Management Systems. This tailored approach ensures that, whether you're just starting out or have an established presence in your industry, we provide the right tools and strategies to bolster your quality assurance efforts.
Our Services
QMS Assessment & Improvement
We conduct a thorough evaluation of your existing Quality Management System, identifying areas for improvement. Our experts work closely with your team to implement necessary changes and enhancements.
SOP Enhancement
We conduct a thorough evaluation of your existing Quality Management System, identifying areas for improvement. Our experts work closely with your team to implement necessary changes and enhancements.
Regulatory Compliance & Risk Management
We assist clients in navigating complex regulatory requirements and managing risks effectively. We provide guidance on regulatory compliance, helping your organization stay in alignment with industry standards and legal mandates.
Quality Assurance Process Improvement
We specialize in enhancing quality assurance processes within your organization, working with you to identify bottlenecks, inefficiencies, and areas where quality can be improved. By implementing process improvements and best practices, we help your business maintain a consistent level of quality
AUDITS
Nuvalez Consulting delivers comprehensive auditing. Our skilled team conducts Internal, External, and Supplier audits, ensuring transparency, compliance, and operational excellence. With a meticulous approach, we identify opportunities for improvement and mitigate risks, fostering trust and growth in your organization. We work with a network of certified local auditors in the USA, Europe, India and China, eliminating any language barriers.
LAUNCH
MANAGEMENT
Launching a pharmaceutical product in today's competitive landscape is a multifaceted challenge, demanding meticulous planning, precise execution, and strategic finesse. Nuvalez Consulting recognizes that successful market entry is a pivotal moment for pharmaceutical companies, and we are committed to partnering with our clients to develop comprehensive launch strategies that maximize product visibility and establish a robust foundation for long-term success. Our experienced team's dedication to launch management is unwavering, and our approach is geared towards ensuring your seamless entry into the market.
Collaborative Strategy Development
We bring a wealth of experience and expertise to the table. We understand that each pharmaceutical product is unique, and our launch management strategy is crafted in close collaboration with your team. We take the time to understand your product, market dynamics, and specific goals, allowing us to develop a tailor-made strategy that aligns with your vision.
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Market Analysis and Planning
A thorough understanding of the market is the bedrock of successful launch management. Our team conducts comprehensive market analysis, evaluating market trends, competitive landscapes, and customer behaviors. This knowledge is instrumental in identifying opportunities and potential challenges, enabling us to plan effectively.
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Long term Success Planning
We don't just stop at a successful launch. We look beyond the immediate launch phase, helping you plan for the long-term success of your product. This includes post-launch monitoring, adaptation to market changes, and ongoing strategies to secure your place in the market.
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ORPHAN DRUG SUPPLY MANAGEMENT
Orphan Drugs by their nature are low volume, high cost and considered critical demand. This can raise challenges with supply as it can be difficult to find the right supply base to cater for small and uncertain demand. However, Nuvalez Consulting are adept at managing Orphan Drugs and helping companies to choose and manage the right suppliers.
Cross-Functional Alignment
Nuvalez Consulting recognizes that successful orphan drug supply management hinges on cross-functional alignment within your organization. We work closely with all relevant teams, including manufacturing, regulatory affairs, quality control, and distribution, to ensure everyone is on the same page and working towards a common goal. Our focus on alignment minimizes miscommunication and ensures a synchronized supply chain.
Global Expertise
Orphan drugs often necessitate navigating complex supply pathways across the world. Nuvalez's team of experts brings global expertise to the table, enabling your organization to navigate international regulations, customs, and logistics seamlessly. We understand the challenges of managing supply chains in unusual locations due to the genetic prevalence of certain illnesses and are well-equipped to overcome these challenges.
Agility and Flexibility
The rare disease and niche product landscape is marked by unpredictability. Nuvalez Consulting ensures that your supply chain is not only resilient but also agile and flexible. We design supply chain strategies that can adapt to unexpected disruptions, ensuring that your product reaches its destination, even in the face of unforeseen challenges.
Vendor Alignment
Selecting the right vendors is critical to a successful supply chain. Nuvalez Consulting works closely with your organization to match vendors to your unique needs. We conduct thorough vendor assessments, evaluating their capabilities, reliability, and cost-effectiveness. Our aim is to establish vendor partnerships that contribute to a streamlined and efficient supply chain.
Efficient Launch Timelines
The timing of product launches is often a make-or-break factor in the pharmaceutical industry. Nuvalez Consulting is dedicated to managing launch timelines with the utmost efficiency. We employ strategic planning and execution to ensure that product launches are well-timed, meeting regulatory requirements and market demand.
LOGISTICS
MANAGEMENT
At Nuvalez Consulting, Logistics Management is approached with utmost precision and attention to regulatory compliance. Our dedicated team utilizes innovative strategies to oversee the seamless movement of drug substances and products, ensuring timely and secure deliveries, and enabling our clients to focus on advancing their critical research and development initiatives.
We take end-to-end ownership
Regulatory Compliance Assurance
Nuvalez Consulting understands that regulatory compliance is non-negotiable in the pharmaceutical industry. Our dedicated team is well-versed in the ever-evolving regulatory landscape, ensuring that all CMC shipments meet the necessary requirements. This includes adhering to guidelines set by the FDA, EMA, and other relevant regulatory bodies.
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Innovative Logistics Strategies
Innovation is at the core of our shipment management service. We utilize cutting-edge logistics strategies to optimize the movement of drug substances and products. This includes route planning, transportation mode selection, temperature-sensitive handling, and packaging, all of which are designed to enhance the security and efficiency of your shipments.
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​Trusted Logistics Partners
Nuvalez Consulting has established relationships with trusted logistics partners and carriers, all of whom have a proven track record in handling pharmaceutical shipments. These partners are carefully selected to ensure the highest level of reliability and security during the transportation process.
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End-to-End Ownership
One of the hallmarks of our service is our commitment to taking the entire shipment management process off our clients' hands. From initial planning to execution and final delivery, we assume full responsibility for the logistics of your CMC shipments, allowing your team to concentrate on the critical tasks of research and development without the burden of managing complex logistics.
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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.
