Services
What We Do
At Biomedista, we are dedicated to enhancing our clients' effectiveness in the healthcare sector through a variety of strategies and initiatives, ensuring the market success of their innovative solutions through these comprehensive services.
- Our Services
- Registration Holder & Regulatory Affairs
- EC Representative Services
- Regulatory Support Services
- Data Management and Reporting
- Market Access Services
Happy Clients
Product's Registered
Projects
Country That We Are Supporting Our Clients
Why Choose Us
Our Added Values
- Flexible Choices
- Experienced Team
- Global Market Access
- Advanced Network
Services Beyond Consultancy
Biomedista serves as a new regulatory team member for your company. Biomedista commits full scale services.
Over a Decade of Expertise in Consulting
The Trusted Ally
With over 10 years of sector experience, we excel in medical device consulting, ensuring regulatory compliance and market approval. Trust our expertise to navigate complex regulations and bring your innovations to market confidently. Biomedista offers a wide range of services to meet the diverse needs of the medical device industry.
Services Region
Biomedista acts as a registration holder, local partner, or affiliate/distributor to achieve successful product registration and market access. By interacting with over 50 countries, we aim to provide our clients with a unique service experience.
Specialized Service Solutions
Our services provide customized solutions to meet the unique needs of clients across various regions.
Registration Holder
We manage the company's product registrations and post-market activities include compliance with MOH/NCA requirements, communication with regulatory bodies, document management and reporting, while holding product registrations in trust for the company's benefit.
Local Partner
We provide registration holder services through a local service provider. Local partners will handle physical tasks like submissions and translations. For specific inquiries such as tenders and advertisements, we will collaborate with local partners alongside our distributor.
Affiliate/Distributor
We function as a dedicated member of your team. We take on the responsibility of managing all distributors, saving your valuable time. With Biomedista, you only need to coordinate with us, simplifying your workflow.
Registration Holder
UAE-Dubai (Headquarter), Egypt and Turkey
Local Partner
KSA, Qatar, Kuwait, Oman, UAE, Bahrain, Morocco, Libya, Algeria, Tunusia, Egypt, Jordan, Lebanon, Israel, Syria, Iran, Iraq, India, Brazil, Albania, Montenegro
Affiliate/Distributor
Niger, Nigeria, Ghana, Congo, South Africa, Ethiopia, Kenya, Tanzania, Pakistan, Afghanistan, Tajikistan, Turkmenistan, Uzbekistan, Kyrgyzstan, Kazakhstan, Azerbeijan, Armenia, Russia, Ukraine, Belarus, Croatia, Serbia, Slovenia, Northern Macedonia, Bosnia and Herzegovina, Kosovo, Sweden, Iceland