Product Development Services

At Memel Biotech we specialize our services in assisting biopharmaceutical companies, researchers and innovators in developing cutting-edge therapies that fall under the category of advanced therapy medicinal products (ATMPs). We focus on all three classes of ATMP including gene therapies, cell therapies, and tissue-engineered products. 

Our product development services include:

Regulatory Strategy and Support. ATMP development is subject to complex regulatory requirements. We can assist in product development by defining regulatory strategies that align with the specific nature of therapy and the complexity of the product. We provide guidance on navigating regulatory pathways, interacting with regulatory authorities, and ensuring compliance with guidelines.

Manufacturing Process Development. Developing scalable and reproducible manufacturing processes for ATMPs is a challenge. We offer expertise in optimizing product methods, ensuring product consistency, addressing quality control issues, and managing the sourcing of raw materials, logistics, distribution, and storage of therapeutic products.

Managing an ATMP development project requires coordination across various disciplines and timelines. Our team provides management expertise to ensure smooth execution and timely completion. We help in assessing potential risks and developing strategies to address them throughout the development lifecycle.

Our product development services for ATMPs offer a comprehensive suite of expertise to guide innovators through the complex process of developing and bringing transformative therapies to patients in need. Together we can ease the process of navigating through regulatory challenges, scientific complexities, and other hurdles to ensure successful ATMP development.

Biomanufacturing Services

Guiding you through every stage of development, Memel Biotech offers ATMP manufacturing services, ensuring the highest standards of quality and compliance. Our services include contract manufacturing of cell-based products and starting materials, performed within state-of-the-art GMP-compliant cleanrooms. We maintain stringent environmental controls to safeguard the integrity of your products throughout the manufacturing process.

From investigational ATMP manufacturing for early and late-stage clinical trials to comprehensive quality control (QC) services, we provide end-to-end support that expedites the journey from laboratory discovery to patient application.

We embrace adaptive manufacturing strategies that accommodate the unique characteristics of each ATMP. By tailoring our processes to your product’s specifications, we optimize yield, minimize variability, and enhance overall manufacturing efficiency.

We emphasize collaboration and open communication throughout the manufacturing journey. Our experienced team partners along with you navigate challenges, address complexities and streamline production, ensuring that your ATMP reaches patients with the highest level of quality and safety

Regulatory Support Services

 Navigating the complex landscape of regulatory approvals is integral to the success of Advanced Therapy Medicinal Products (ATMPs) development. Memel Biotech offers strategic regulatory support services that align with your ATMP development goals. 

Clinical Trials Support: Our expertise extends to providing clinical trials support, covering Phase I-IV clinical research services within Europe. With a deep understanding of the regulatory requirements and a track record of successful trial execution, we are equipped to help you navigate the intricacies of clinical development, from study design to regulatory submissions.

Drug Development Consulting: We offer strategic drug development consulting services tailored to biotech and medtech companies. Our expert guidance streamlines early and pre-clinical development, facilitating decisive milestones that enable earlier and more efficient exit and reinvestment strategies.

ATMP Development Regulatory Affairs: Drawing insights from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), we provide expert regulatory affairs support specific to ATMP development. Our team is well-versed in the regulatory guidelines outlined by both EMA and FDA for ATMP development and the evolving landscape of ATMP regulations, ensuring your products align with the latest requirements. From initial concept to final commercialization, we offer guidance that ensures your ATMPs meet the standards set forth by regulatory bodies.

Approvals for State Medicines Agencies: Memel Biotech takes the lead in navigating the approvals process with State Medicines Agencies, ensuring compliance with regional regulations. We leverage our experience to facilitate the necessary approvals, enabling you to advance your ATMPs seamlessly through the development pipeline.

With Memel Biotech as your regulatory partner, you can confidently navigate the intricate regulatory pathways, ensuring your ATMPs not only meet the highest standards of safety and efficacy but also progress smoothly toward market authorization.