Guidance
In house and partnered consulting services for manufacturing, healthcare economics
In house and partnered consulting services for manufacturing, healthcare economics
Whether you want a discussion on your existing process that you wish to transfer in, or want some in-depth analysis as a stand-alone piece of consulting work, we’re here to help.Our services are designed to help you assess and optimize cell therapy manufacturing processes, ensuring they meet the highest standards of quality, efficiency, and compliance. With extensive expertise in cell therapy production, we provide comprehensive evaluations of your manufacturing workflows, identifying critical areas for improvement. From raw material selection and cell culture optimization to scale-up strategies and quality control integration, our experts guide you through every aspect of the production process. Whether you are in early development or seeking to enhance existing operations, we deliver tailored solutions to maximize productivity and ensure product consistency.
Regulatory compliance is a cornerstone of our consultancy offerings. We help you navigate the complex regulatory landscape for cell therapy manufacturing, ensuring your processes align with guidelines from agencies such as the EMA, FDA, and other global authorities. Our team conducts in-depth gap analyses, process validation reviews, and risk assessments to ensure your facility operates at peak performance and adheres to all regulatory requirements. By partnering with us, you gain access to industry-leading expertise and actionable insights that streamline your manufacturing operations, reduce costs, and accelerate your path to market.
In addition to these services, we offer specialized guidance for Advanced Therapy Medicinal Products for Hospital Exemption (ATMP-HE) in Poland, tailored to help you navigate the unique regulatory framework and accelerate testing timelines. Our experts are well-versed in the Polish healthcare and regulatory landscape, providing strategic advice on obtaining approvals, meeting compliance requirements, and streamlining processes specific to hospital exemption pathways. We work closely with your team to develop tailored manufacturing and testing strategies that align with ATMP-HE standards, enabling faster access to clinical settings. By leveraging our deep local expertise, we help you reduce barriers, optimize workflows, and bring your innovative therapies to patients more efficiently.
We are proud to collaborate with Remap Consulting, a leading authority in pricing, reimbursement, and market access strategies, to provide specialized support in the development and market access of innovative therapies. Renowned for its expertise in pharmaceutical and biopharmaceutical products, Remap Consulting offers services including payer value identification, price optimisation and health technology assessments (HTAs). These tailored solutions help therapies demonstrate value to healthcare systems, payers, physicians and patients.
Remap Consulting’s expertise is particularly valuable for start-up biotech’s aiming to secure funding from venture capital (VC) firms. Through detailed assessments, companies gain critical insights into the market potential and competitive landscape of their products. These data-driven insights empower biotech firms to present compelling cases to investors, showcasing the long-term viability and value of their therapies. By integrating Remap Consulting’s expertise with a deep understanding of the therapeutic landscape, we deliver comprehensive solutions that address both the financial and clinical challenges of bringing advanced therapeutics to market. This approach strengthens funding proposals, enhances strategic decision-making, and positions companies for success in a competitive and rapidly evolving healthcare market
