Streamlined Project Management and Regulatory Compliance for Your Success!
"With effective project management, we can streamline processes, quickly identify and resolve bottlenecks, and enhance collaboration among our diverse teams—Upstream, Downstream, Quality Control, Quality Assurance, and Regulatory Affairs."
We take responsibility for your project from concept development to production, ensuring timely and high-quality results.
Our interdisciplinary teams optimize your production processes and promote efficient collaboration.
We ensure all processes comply with current regulations and support you through approval procedures.
CMC Project Management
Everything you need!
We provide expert project management services for the development of manufacturing processes for biologics, including New Biological Entities, biosimilars, and Advanced Therapy Medicinal Products (ATMPs).
Our methodology encompasses comprehensive project oversight and the strategic leadership of a highly skilled, interdisciplinary team of professionals specializing in process optimization, scale-up, analytical methods, quality assurance, regulatory compliance, stability studies, and validation.
Our mission is to design and implement robust, compliant processes that meet all regulatory standards for both clinical and commercial production. Partner with us to realize your vision with precision and excellence!
Comprehensive Project Management & Holistic Project Control
We take responsibility for all aspects of your project, from the initial concept development to successful commercial production.
This includes detailed planning, precise control, and thorough monitoring of all project phases. With this holistic approach, we ensure that your project is completed on time, within budget, and to the highest quality standards.
We act as your central point of contact, facilitating a smooth process so that you can focus on your core competencies.
Interdisciplinary Team Leadership & Optimized Production Processes
Our strength lies in leading experienced, interdisciplinary teams.
We bring together experts from various fields to ensure optimal collaboration and seamless information exchange.
This enables us to establish efficient and cost-effective production processes. Through our experienced CMO management, we optimize the production of your biologics and ensure that all processes operate seamlessly together.
Regulatory Compliance & Regulatory Expertise
Adhering to current regulatory requirements is our top priority.
We ensure that all processes, from development to production, comply with applicable regulations and guidelines.
Our regulatory expertise minimizes potential risks during approval processes and ensures that your products meet the highest safety and quality standards.
We assist you in creating the necessary documentation and
guide you through the entire approval process
Customer Value
Our collaboration is based on close coordination to understand your specific requirements and develop tailored solutions. We manage the detailed planning, oversight, and monitoring of all project phases, from project plan creation to milestone tracking. We prioritize clear communication and coordination among all parties involved to ensure a smooth and efficient project process.
Our transparent communication keeps all stakeholders informed at every stage. Our comprehensive risk management helps identify and address potential issues early on. We also ensure compliance with the highest quality standards and all relevant regulatory requirements.
By leveraging our extensive network of CMOs and our expertise in CMC process development, we guarantee the successful achievement of your project goals.
Reference
Type: mid-sized pharmaceutical company
Topic: biosimilar development
Goal: process charaterization, CDMO selection
We led the analysis of existing process data, facilitated risk assessments, and designed experimental studies to establish critical process parameters.
We managed the CDMO selection and development activities, ensuring adherence to timelines and quality standards.
Furthermore, we supported the client in preparing for process validation and regulatory filings, including the review and development of necessary documentation to address regulatory agency objections and facilitate a new drug entity submission.
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Process
Characterization
Our process characterization services ensure your product quality. Our focus is on analyzing critical process parameters and developing TPPs and CQAs for a clear understanding of the product. We define Critical Control Parameters (CPPs) and integrate them into a robust control strategy.
Qualification & Validation
Our service focus includes document creation for compliance, risk-based project management to enhance quality and safety, and GMP-upgrades to ensure facilities meet evolving regulations and adapt to product changes. We ensure accuracy, efficiency, and regulatory compliance.
Process
Development
Our experts assist in creating stable, high-performance cell lines and optimize methods to ensure product quality and reproducibility. We enhance the growth and productivity of your cell cultures, design efficient downstream processes, and ensure the stability and effectiveness of your products.
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