Services
Project Management
We understand that successful project management goes beyond simply delivering on time and within budget. That’s why our approach is centered around collaboration, communication, and a relentless focus on delivering value to our clients. Whether you’re implementing new software, upgrading infrastructure, or purchasing new production equipment, our team of experienced project managers is here to guide you every step of the way.
What We Offer
Comprehensive Project Planning
We work closely with stakeholders to define project goals, scope, and deliverables, developing detailed project plans that account for timelines, resources, and potential risks.
Stakeholder Engagement and Communication
Effective communication is key to project success. Our project managers facilitate clear and open communication between all stakeholders, ensuring alignment, transparency, and timely resolution of issues.
Risk Management and Mitigation
We proactively identify and assess potential risks throughout the project lifecycle, implementing mitigation strategies to minimize disruption and maximize project success.
Vendor and Third-Party Management
If your project involves working with external vendors or third-party providers, we’ll manage those relationships on your behalf, ensuring that all parties are aligned and delivering according to agreed-upon terms and expectations.
Management consulting
Our approach to management consulting is rooted in collaboration, customization, and a deep understanding of the pharmaceutical industry. We partner with our clients to identify their unique challenges and opportunities, developing tailored solutions that address their specific needs and goals.
What We Offer
Strategic Planning and Business Development
We work with pharmaceutical companies to develop robust strategic plans that align with their long-term vision and objectives. Whether you’re entering new markets, launching new products, or optimizing your portfolio, we can help you develop a roadmap for success.
Operational Excellence
We help organizations streamline their operations and improve efficiency across the value chain. From supply chain optimization to lean manufacturing principles, we identify opportunities for process improvement and cost reduction to drive sustainable growth and profitability.
Organizational Change Management
We support organizations through periods of change and transformation, helping them navigate challenges such as mergers and acquisitions, restructuring, and cultural transformation. Our change management experts provide guidance and support to ensure smooth transitions and successful outcomes.
Regulatory Compliance and Quality Management:
With our deep understanding of regulatory requirements and quality management systems, we help pharmaceutical companies achieve and maintain compliance with industry standards and regulations. We provide guidance and support to ensure that your organization meets the highest standards of quality and compliance.
Validation
Our validation experts understand the complexities of regulatory requirements and the importance of a systematic and thorough approach to validation activities. We work closely with your team to develop a validation strategy that aligns with your specific needs, ensuring that your systems, processes, and procedures meet the highest standards of quality and compliance.
What We Offer
Computer System Validation (CSV)
We specialize in validating computerized systems used in pharmaceutical manufacturing, including Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP) systems, and more. Our CSV services ensure that these systems are implemented and maintained in a manner that meets regulatory requirements and industry best practices.
Equipment Qualification
We provide equipment qualification services to ensure that manufacturing equipment, instrumentation, and facilities meet predefined acceptance criteria and perform consistently within specified operational ranges. Our validation scope cover Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as necessary.
Process Validation
Our process validation services help you demonstrate that your manufacturing processes consistently produce products that meet predetermined specifications and quality attributes. Whether you’re validating a new process or performing ongoing validation activities, we can assist you in developing and executing validation protocols to ensure compliance and product quality.
Serialization
Our approach to serialization is rooted in a deep understanding of regulatory requirements, industry best practices, and emerging technologies. We partner with pharmaceutical companies to develop and implement serialization strategies that not only meet compliance mandates but also deliver tangible benefits in terms of supply chain visibility, product security, and brand protection.
What We Offer
Serialization Strategy and Roadmap
We work closely with our clients to assess their serialization needs and develop a customized strategy and roadmap for implementation. Whether you’re navigating regulatory requirements such as DSCSA (Drug Supply Chain Security Act) in the United States or FMD (Falsified Medicines Directive) in Europe, we can help you develop a roadmap that aligns with your business objectives and compliance obligations.
Technology Evaluation and Selection
With a plethora of serialization solutions available in the market, selecting the right technology partner is critical. We assist our clients in evaluating and selecting the most suitable serialization solution based on factors such as scalability, interoperability, and regulatory compliance.
Implementation and Integration
Our team of serialization experts manages the end-to-end implementation process, from system configuration and testing to deployment and integration with existing IT systems such as ERP (Enterprise Resource Planning) and MES (Manufacturing Execution System). We ensure that your serialization solution seamlessly integrates into your existing infrastructure while minimizing disruption to your operations.
Validation and Compliance
We provide validation services to ensure that your serialization solution meets regulatory requirements and industry standards. From IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) to validation documentation and audit support, we help you demonstrate compliance and ensure the integrity of your serialization data.
Werum PAS-X
We understand that the successful implementation of Werum PAS-X requires a deep understanding of both the software and the intricacies of pharmaceutical manufacturing processes. Our team of experts brings years of experience in both domains, ensuring a seamless integration of PAS-X into your existing infrastructure.
What We Offer
Consultation and Planning
We work closely with your team to assess your specific requirements and develop a customized implementation plan that aligns with your business objectives and regulatory compliance needs.
Installation and Configuration
Our skilled technicians handle the installation and configuration of Werum PAS-X, ensuring that it is optimized to meet your workflow requirements while maintaining compliance with industry standards.
Integration with Existing Systems
We specialize in integrating Werum PAS-X with other critical systems such as ERP, LIMS, and SCADA, enabling seamless data exchange and real-time visibility across your entire manufacturing operation.
Get in Touch with us
Whether you’re implementing new software, upgrading infrastructure, or launching a digital transformation initiative, our team of experienced project managers is here to guide you every step of the way.