YOUR TRUSTED PARTNER FOR ALL ASPECTS OF PRODUCT DEVELOPMENT

BIOLOGICS & BIOSIMILAR DEVELOPMENT: NAVIGATING THE COMPLEXITIES WITH OUR EXPERTISE

How can we help you?

Technology Transfer

Design your next projects and milestones supported with our deep science and unique "Know How" in technology transfer of Add-Value Medicines e.g. Biosimilars and mRNA-based Therapeutics.

Bioanalytical Services

Discover our Outstanding experience in developing bioanalytical methods (PK, PD, ADA and NAb), validation and sample analysis.

Partnerships

Our Team will help you to connect with international biosimilars companies who are looking for trusted partners in the MENA region and vice versa.

Biosimilar & Biologics

Development, Manufacturing, Commercialization, Distribution, International Partnerships & Scientific Trainings.

Our mission is to offer comprehensive counsel and invaluable insights into the FDA's perspective throughout the entire biosimilar product development lifecycle. We understand the significance of navigating the complex world of biosimilars, and our team of esteemed biosimilar expert consultants possesses decades of experience across every stage of product development.

Our dedicated consultants bring a wealth of knowledge and expertise to the table, ensuring that our clients receive the highest level of guidance and support. From initial concept and strategy formulation to preclinical and clinical development, manufacturing, and regulatory submissions,

At Biosimitix, we are committed to being your trusted partner in biosimilar development, helping you navigate regulatory complexities and bring your innovative products to market with confidence.

Pre-clinical & Clinical studies

• Performing (pre) clinical studies (from Plan to Report) at specialized CROs Successfully inspected by US FDA, EMA and Jordan FDA
• Cynomolgus monkey, Dogs, rabbits, rats and mice species. • Deep experience in Biologics and Biosimilars • CRO Licensed for >80 Beds in site • Fully equipped emergency rooms and accredited diagnostic lab • Database for more than 6,000 healthy male and female participants • Barcode system for samples collection
• Biological Fluids (Blood and Blood Products) from human and animal

Regulatory Affairs

Our unparalleled combination of industry, government, and consulting experience sets us apart from the rest, making us the go-to choice for businesses seeking regulatory expertise. Our services are recognized as best-in-class by clients worldwide. At Biosimitix, we strive to help companies navigate complex regulatory environments, ensuring compliance with laws and regulations while fostering growth and innovation. Our regulatory strategy development, submission support, compliance assessments, and post-market surveillance services are tailored to meet your unique needs.
our consultants are equipped with the skills and insights necessary to drive successful outcomes. We recognize the evolving landscape of biosimilar development and stay up-to-date with the latest regulatory guidelines and industry trends. By working closely with our clients, we provide tailored solutions that address their unique challenges and maximize their chances of regulatory success.

Portfolio

Our Amazing Customers

We present an extensive spectrum of services tailored to meet the technical requisites and advisory needs of BioTech Companies.
Whether you are in the process of initiating the development of new biologics/biosimilars or overseeing an established entity, our objective revolves around fortifying your accomplishments and facilitating your progression. Our central aim is to assist you in adeptly navigating the various stages of drug development within its lifecycle.

We Enable Your Future Medicine

Would you like to start a project with us?

Are you seeking to develop biosimilars and establish connections with international companies?

Are you engaged in the development of bioanalytical methods and seeking exceptional expertise? 

Are you in search of a dependable Contract Research Organization (CRO) that conducts a range of pre-clinical and clinical studies adhering to rigorous GxP standards?