About Us
Welcome! We Are a Boutique CAR T-Cell Advisory Company.
Everything CAR T-Cell.
Bold Strategies for Navigating Cell and Gene Therapy Development.
In the rapidly evolving landscape of medical breakthroughs, CAR T-cell Advisory by Medrego emerges as a beacon of innovation and support. Our partnership with clients goes beyond conventional consultancy; we immerse ourselves in the intricate processes of cell and gene therapy product development. We always keep an eye on the latest up-to-date regulatory changes, so you can stay ahead of the game.
Our goal? To empower our clients to overcome the multitude of challenges presented by the complex regulatory environment, manage potential risks effectively, ensure the unwavering quality and safety of their products, and ultimately, achieve successful market launches.
This dedication not only accelerates the advancement of medical science but also has a profound impact on the lives of patients worldwide.
Comprehensive Expertise in Cell and Gene Therapy Development
At the core of our approach lies a deep understanding of the cell and gene therapy sector. Our team of experts brings a wealth of knowledge and experience, offering comprehensive solutions that are tailored to the unique needs of each client. From early conceptualization to the final stages of product launch, we provide insights and strategies that are both innovative and practical.
Navigating the Regulatory Maze
One of the most daunting aspects of bringing a new therapy to market is navigating the complex regulatory landscape. Regulations can vary significantly by region and are often subject to change, posing a substantial challenge to companies looking to develop and distribute their products globally. Our advisory services are designed to demystify this process, offering clear guidance and support every step of the way. We help our clients understand regulatory requirements, prepare for inspections and audits, and develop strategies to meet the highest standards of compliance.
Even more, we are the ones who help government and municipality bodies develop and establish up-to-date regulations and guidelines to support innovative CAR T-cell treatment adoption.
Risk Management and Quality Assurance
Managing risks and ensuring product quality are paramount in the development of cell and gene therapies. These products often involve novel and complex technologies, making them subject to a high degree of scrutiny from regulatory bodies.
Our risk management strategies are proactive and comprehensive, identifying potential issues early in the development process and implementing measures to mitigate them. Similarly, our commitment to quality assurance is unwavering, ensuring that every product meets or exceeds the rigorous standards set forth by regulatory agencies, thereby safeguarding patient safety.
Ensuring Successful Market Entry
The ultimate goal of any cell and gene therapy development project is a successful market entry. This requires a strategic approach that encompasses not only regulatory compliance and product quality but also market analysis, positioning, and post-market surveillance.
Our team supports clients through this entire journey, leveraging our industry insights to maximize their chances of success. We understand the importance of not just reaching the market but doing so in a way that ensures the product’s long-term viability and impact on patient care.
Making a Meaningful Impact on Patients’ Lives
At the heart of everything we do at CAR T-cell Advisory by Medrego is a commitment to making a meaningful impact on patients’ lives.
Cell and gene therapies hold the promise of treating, and potentially curing, a range of diseases that have long been considered untreatable. By partnering with our clients, we are not just advancing the field of medicine; we are also offering hope to patients and their families. Our work is driven by the belief that every person deserves access to the best possible care, and we are dedicated to making that vision a reality.
In conclusion, CAR T-cell Advisory by Medrego stands at the forefront of cell and gene therapy development, offering a unique blend of expertise, innovation, and dedication. Our comprehensive approach ensures that our clients are well-equipped to navigate the complexities of product development, regulatory compliance, and market entry.
MEET OUR TEAM
PhD, Dr.biol. Janis Ancans
Scientific team leader. CAR T-cell regulatory expert. Experienced with cell and gene therapy, CAR T-cell product (ATMP) regulatory framework and authorization. Clinical development and supply chain management.
Mr. Normunds Daudiss
Master in Business Administration & Finance. Responsible for strategic concepts, new business development, and market access plans. 15 year expertise in Biotech and Healthtech product commercialization.
M.Sc. Martins Boroduskis
Researcher and Senior expert. Research activities in the field of human and animal cell biology, improvement of the therapeutic potential of cell therapies.
Our vision
We are the leading CAR T-cell regulatory and clinical guideline development expert for Government bodies and best partner for CAR T-cell therapy manufacturers and providers.
CAR T-cell Advisory by Medrego
Medrego is a multi-profile company targeting the area of Life Sciences and Biotechnology.
Besides our Advisory and Consulting segment, we are also a manufacturing and research and development organization ourselves. Focusing on regenerative solutions, such as Stem Cell Therapy for the animal market (dogs, horses). Stem cells in this field are used for recovery after injuries, improvement of performance (energy boost), and productivity increase.
Learn more at: www.medrego.com
Our core values:
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You can book a FREE 15-minute online phone consultation about your particular case with our Business Development consultant.