Emendo Research & Development

We deliver innovative and exceptional results that drive your success in the fast-paced world of medical device and pharmaceuticals, using a combination of our comprehensive toolbox and scientific expertise.

ABOUT US

Utilizing Best Practice Knowledge

Our Research and Development team is specialized in enhancing the development and optimization of pharmaceutical and medical device industries. We utilize best-practice knowledge gained from working with numerous national and international biotech/pharma and medical device companies.

With a deep understanding of industry trends and challenges, we provide a large variety of services ranging from practical hands-on lab work, prepare the required technical and quality documentation, complex project management to supporting top management with strategies, insights and how to execute – we call it R&D excellence!

Empower Innovation Through Industry Expertise and Strategic Excellence

HOW

Custom Solutions for R&D Excellence

We know that each client is unique, with their own specific goals and challenges. We work closely with your areas to gain a deep understanding of your organization’s needs and aspirations. Our collaborative approach enables us to tailor our solutions precisely to your requirements, providing you with strategies that not only live up to your technical requirements but also drive sustainable growth and competitive advantage.

Partnering with us gives you access to a strong team of scientific professionals who are passionate about driving progress in the field. We provide a comprehensive range of services, equipped with the highest industry standards for R&D activities and project governance, covering both the Pharmaceutical and Medical Device industry.

Our pharmaceutical services cover various expertise areas, such as CMC Advice for regulatory compliance across your product’s life cycle, Manufacturing and Development Support to optimize your manufacturing processes ensuring efficiency, compliance, and cost-effectiveness and Analytical Development which helps with validation, testing, and data interpretation.

We specialize in tailoring solutions with our R&D excellence approach combining expert guidance in evolving landscapes like Combination Devices, Sustainability and Quality with project management and LEAN tools.

Regulatory compliance is a critical aspect of pharmaceutical development. Our CMC (Chemistry, Manufacturing, and Controls) experts provide strategic guidance and support, ensuring compliance with regulatory requirements throughout the entire product life cycle. From early strategy development, dossier preparation to regulatory interactions, we help and support you to navigate the complex landscape of CMC regulations and avoid expensive pitfalls.

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Our team specializes in providing scientific and tailored solutions to optimize and transfer your manufacturing and development activities. From process design, validation, and optimization to writing GMP documents, we ensure that your project activities are efficient, compliant, and cost-effective. Our Scientific consultants can also support with GMP activities like contamination control strategies and cleaning.

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Accurate and reliable analytical methods are essential for pharmaceutical development. Our team of experts excels in analytical method development and validation (ICH Q2), analytical testing, and data interpretation. We help you enhance the quality and compliance of your analytical processes to make informed decisions and meet regulatory requirements. Our scientific consultants take pride in close collaboration with all stakeholders and are often seen in the laboratory working with the technicians.

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As the pharmaceutical landscape evolves, combination products that integrate drugs, devices, and biologics are gaining prominence. Our team is specialized in providing expertise in specifying, developing, or sourcing combination devices that fulfill the regulatory requirements. We assist you in navigating the unique challenges and ensuring compliance with applicable regulations.

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Quality is at the core of every successful pharmaceutical product. We offer comprehensive quality assurance and quality control services, including auditing, gap and risk assessment, and quality system implementation. Our focus is to help you establish and maintain a robust quality management system that fosters operational excellence and patient safety. We provide guidance but also hands-on support on quality principles, GxP regulations and compliance requirements.

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At Emendo R&D, we’re your dedicated partner in clinical trial supply. Our expert team ensures that you have the right product at the right site when the patient needs it, vital for trial success. We have the capabilities to manage all phases of your clinical trial supply chain from process building to execution. With our comprehensive services, attention to detail, and commitment to quality, we provide efficient supply chain management.

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With our industry experience, analytical capability, and proactive approach, we excel in leading and facilitating difficult activities in R&D with a seamless experience for the customer. Our experts ensure efficient project control together with a strong focus on the innovation and business drivers of your company. We manage projects, facilitate decision-making processes, resolving scientific issues, ensuring smooth coordination and timely execution of your projects. Business critical issues, Tech Transfer and Operational Readiness projects are typical examples where Emendo R&D take the lead to support our customers. Of cause all in line with the regulations and GMP – true R&D excellence!

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Our expertise spans early technology development in material sciences and formulations, adhesives, coatings, sensors, and sustainable designs. We excel in planning and translating user needs, innovate devices complying with MDR ensuring effective project management for seamless execution or participate as development specialist in your development team.

Our commitment to quality shines in product development, verification, and validation, where we ensure compliance MDR and safety. Sustainability must be incorporated from the very beginning when developing a new innovative device. If not, we can lead you through the sustainability assessment of your current product portfolio and pinpoint where you will make the greatest impact on carbon footprint reduction.

Our team excels in early-stage technology development, with a focus on material and polymer sciences, adhesives and coating technology, wound care products, implants, sensor technology, and sustainable (Circularity for Zero/minimized carbon footprint) device designs. We combine scientific knowledge and innovative thinking to help you develop cutting-edge technologies that push the boundaries of medical device advancements. We either work as an integrated part of your technology team or we take the project management role to maturation of the new technology for the next generation of products.

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Need-driving innovation with clear understanding of user-needs, buyers and payers is crucial for success. As an integrated part of your team, we build strong product concepts. Our experience with identifying unmet needs, collecting key user insights, building target profiles, mapping product pathways, and creating evidence strategies will ensures lower development cost, shorter time to market, validated value propositions, and a strong product portfolio. With our project management role, we ensure smooth coordination and effective execution of the innovative front end process.

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Our team is committed to helping you transform early concepts into tangible realities. We set user and device specifications based on defined requirements, develop prototypes for testing purposes, and establish necessary test methods. We are skilled in MDR ensuring the required documentation is in place. With a sustainable focus, we select materials and designs that align with environmental considerations, promoting both functionality and sustainability. When the device finally is validated, we assist with the design transfer process.

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As the pharmaceutical landscape evolves, combination products that integrate drugs, devices, and biologics are gaining prominence. Our team is specialized in providing expertise in specifying, developing, or sourcing combination devices that fulfill the regulatory requirements. We assist you in navigating the unique challenges and ensuring compliance with applicable regulations.

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Compliance and quality are paramount in the medical device industry regulated by MDR/IVDR Our experts guide you through the design control process, implement rigorous product risk management, and develop verification plans, protocols, and reports with statistical rationales. We conduct thorough lab and pre-clinical testing, usability testing, and follow up on clinical data, ensuring the safety and effectiveness of your medical devices. Our team also assesses product risks and implements initiatives to reduce and minimize potential risks.

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Our team prepares data-driven sustainability strategies that match your environmental ambitions and carbon footprint targets. We achieve it by collecting and mapping data, assessing environmental impact of products, packaging, and processes, and then outlining and realizing improvements. Our goal is to incorporate environmentally conscious practices into your team’s daily work. We also assist in supplier identification and qualification ensuring they meet your sustainability targets.

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Together with our significant industry experience, we offer seamless collaboration with our customers – we call this R&D excellence. Our experts ensure efficient project control together with a strong focus on the innovation and business drivers of your company. We manage projects, facilitate decision-making processes, resolving scientific issues, ensuring smooth coordination and timely execution of your projects. Of cause all in line with the MDR/IVDR requirements – true R&D excellence!

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Our Good Stories

WHITE PAPER

CMC Strategy – 8 Common Pitfalls

What are the most common pitfalls faced by pharmaceutical R&D departments today? Better yet, how can you avoid them and mitigate the risk of delays across the board? Sanne Valentin, CMC Advisor, and Christine Weber, Principal Scientific Consultant, from the Emendo R&D team shares their insights from over 25 years of working with CMC.

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Our R&D Team

Our people are the true driving force behind our success. We have assembled an incredible team of experts who come from diverse backgrounds, but they all share a common thread: a genuine passion for their industry and an unwavering commitment to exceeding our clients’ expectations.

Beyond Emendo

Our people are the true driving force behind our success. We’ve assembled an incredible team of experts who come from diverse backgrounds, but they all share a common thread: a genuine passion for their industry and an unwavering commitment to exceeding our clients’ expectations.

Join Us

Are you ready to embark on an incredible journey? Do you want to become a part of a vibrant and diverse community where like-minded individuals come together to explore, learn, and grow? We are always on the lookout for motivated and talented people.

HAVE A QUESTION

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