Key Highlights:

• Dubai Science Park offers 100% foreign ownership with specialized biosafety-compliant laboratory facilities for life sciences companies.
• Emirates Drug Establishment (EDE) now regulates all pharmaceutical and biotech operations under Federal Decree-Law No. 38 of 2024.
• Minimum share capital starts at AED 50,000 for standard biotech operations, increasing to AED 300,000 for manufacturing activities.
• The UAE targets localization of pharmaceutical production by 2030, creating significant opportunities for biotech manufacturing ventures.

Dubai has emerged as the undisputed regional leader in biotechnology and life sciences, driven by the UAE government’s ambitious vision to transform the emirate into a global scientific research hub. 

With the recently enacted Federal Decree-Law No. 38 of 2024 and the establishment of the Emirates Drug Establishment (EDE) as the new regulatory authority, Dubai offers unprecedented opportunities for biotech entrepreneurs seeking to establish their ventures in the region.

If you want to set up your biotechnology company in Dubai, keep reading this detailed article. Always refer to UAE official sources or a trusted business consultant for the latest updates and assistance. 

Disclaimer: This article is for informational purposes only and should not be considered as legal, financial, or professional advice. Regulations in the biotechnology sector may change frequently. Always consult UAE official sources for the latest updates on regulations, pricing, and costs.

Key Free Zones for BioTech Companies

1. Dubai Science Park: The Premier Life Sciences Hub

Dubai Science Park (DSP), formerly known as DuBiotech, stands as the Middle East’s first and only commercial jurisdiction exclusively dedicated to life sciences. 

Established in 2005 by the TECOM Group, this purpose-built free zone hosts over 400 companies across biotechnology, pharmaceutical research, environmental sciences, and medical device development.

The park offers state-of-the-art laboratory facilities, including biosafety level-compliant spaces, shared research infrastructure, and plug-and-play laboratory shells that companies can customize according to their specific needs. 

DSP provides comprehensive support for biotech ventures, from startups developing innovative diagnostics to established pharmaceutical giants conducting regional research and development.

2. JAFZA: Manufacturing and Export Excellence

Jebel Ali Free Zone (JAFZA) serves as Dubai’s premier destination for large-scale pharmaceutical manufacturing and global distribution operations. 

Home to international pharmaceutical companies like Sanofi and GlaxoSmithKline, JAFZA offers strategic advantages, including direct access to Jebel Ali Port and Al Maktoum Airport, enabling efficient export to over 3 billion consumers across the MENA, Africa, and South Asia regions.

The zone provides industrial land, modern warehousing facilities, and on-site customs clearance capabilities, making it ideal for biotech companies focused on biomanufacturing and pharmaceutical production at scale.

3. DMCC: Advanced Trading and Commodities Hub

Dubai Multi Commodities Centre (DMCC) has evolved into a significant player in the pharmaceutical ingredients and medical commodities trading sector. 

The zone offers sophisticated trading infrastructure and regulatory frameworks that support biotech companies involved in the import, export, and trading of pharmaceutical raw materials, active pharmaceutical ingredients, and specialized medical compounds.

4. Dubai Healthcare City: Clinical Research and Medical Innovation

Dubai Healthcare City (DHCC) represents the emirate’s regulated healthcare ecosystem, providing direct integration with hospitals, medical universities, and clinical research facilities. 

This free zone is particularly attractive for biotech companies conducting clinical trials, developing medical diagnostics, and creating patient-centered healthcare solutions.

DHCC offers specialized healthcare facility licenses, professional licenses for medical practitioners, and commercial licenses that enable biotech companies to operate within Dubai’s healthcare infrastructure while maintaining close proximity to end-users and clinical partners.

Government Policy and Strategic Vision

1. Dubai Industrial Strategy 2030

The UAE’s national strategic framework positions biotechnology as a cornerstone of the country’s knowledge-based economy transformation. 

Dubai Industrial Strategy 2030 specifically identifies pharmaceuticals and medical equipment as priority subsectors, with ambitious targets to increase manufacturing output and attract global biotech leaders to establish regional operations.

The strategy encompasses 75 strategic initiatives designed to generate an additional AED 160 billion by 2030, with significant focus on biotechnology, pharmaceuticals, and advanced manufacturing sectors that leverage Dubai’s strategic location and business-friendly environment.

2. Emirates Drug Establishment (EDE): The New Regulatory Authority

The establishment of the Emirates Drug Establishment in September 2023 marks a transformative shift in the UAE’s pharmaceutical and biotech regulatory landscape. 

EDE has assumed comprehensive oversight responsibilities from the Ministry of Health and Prevention, including pharmaceutical product approval, market surveillance, and the development of UAE-specific pharmacopeia standards.

Under the new Federal Decree-Law No. 38 of 2024, EDE provides streamlined approval processes, enhanced regulatory protections for innovative medical products, and strengthened pharmacovigilance systems that align with international best practices while maintaining efficiency for market entry.

Market Opportunities and Emerging Niches

1. Personalized Medicine and Genetic Testing

The UAE is experiencing rapid growth in personalized medicine applications, driven by national initiatives like the Emirati Genome Program and increasing demand for precision healthcare solutions. 

The personalized medicine market in the UAE is projected to reach USD 5.1 billion by 2033, growing at 9.8% CAGR, creating substantial opportunities for biotech companies developing genetic testing, pharmacogenomics, and personalized therapeutic solutions.

2. Digital Health and AI-Driven Diagnostics

Dubai’s position as a technology innovation hub creates unique opportunities for biotech companies integrating artificial intelligence, machine learning, and digital health platforms. 

The convergence of Dubai’s advanced IT infrastructure with its growing life sciences sector enables the development of AI-driven diagnostic tools, telemedicine platforms, and digital therapeutics that serve both local and regional markets.

3. Biotechnology Manufacturing and Biosimilars

The UAE government’s commitment to localizing 50% of pharmaceutical production by 2030 presents significant opportunities for biotech companies involved in biologics manufacturing, biosimilar development, and specialized pharmaceutical production. 

This strategic initiative, supported by substantial government investment and infrastructure development, creates a favorable environment for companies establishing manufacturing operations in Dubai’s free zones.

Legal and Regulatory Framework

The Federal Decree-Law No. 38 of 2024 introduces comprehensive reforms to the UAE’s medical products regulation, expanding coverage to include biopharmaceuticals, genetically modified organisms for medical use, and biobanks. 

The law provides a one-year grace period for existing entities to achieve compliance, demonstrating the government’s commitment to supporting industry transition while maintaining rigorous safety standards.

Key regulatory enhancements include strengthened marketing authorization processes, expanded pharmacovigilance requirements, and enhanced intellectual property protections for innovative medical products. The law also introduces fast-track approval pathways for innovative therapies and conditional approvals for treatments addressing life-threatening conditions.

Business Structure Options

1. Free Zone Limited Liability Company (FZ-LLC)

The FZ-LLC structure represents the most popular choice for biotech companies establishing operations in Dubai’s free zones. This business structure offers 100% foreign ownership, full profit repatriation rights, and tax exemptions that can extend up to 50 years depending on the specific free zone jurisdiction.

For standard biotech operations, the minimum share capital requirement is AED 50,000. However, companies engaged in manufacturing and production activities within specific segments, including therapeutics, medical devices, or specialty supplies, may require increased minimum capital of AED 300,000.

2. FreeLancer Permit for Individual Specialists

Dubai’s free zones offer Freelancer permits are designed for individual biotech professionals providing specialized services such as regulatory consulting, clinical research support, or technical advisory services. This permit structure enables qualified professionals to operate independently while maintaining the flexibility to serve multiple clients within the free zone ecosystem.

Annual Operating Expenses and Fee Structure

Based on the latest Cabinet Resolution No. 40 of 2025, biotech companies operating in Dubai face a comprehensive but competitive fee structure. 

The Emirates Drug Establishment has implemented standardized fees for pharmaceutical and biotech operations, including manufacturing facility licensing at AED 50,000 annually and marketing authorization fees starting at AED 7,000 for pharmaceutical products, and import permit fees calculated at 1% of invoice value with a minimum of AED 200 per invoice.

Trade license fees vary significantly based on business activities and free zone selection, ranging from AED 10,000 to AED 50,000 annually. Companies should budget for establishment cards at AED 1,825 annually, along with visa processing costs and mandatory health insurance requirements for all employees.

Company Formation Process

1. Documentation Requirements and Business Planning

Successful biotech company formation in Dubai requires comprehensive documentation that demonstrates technical expertise, financial capability, and regulatory compliance understanding. 

Essential documents include detailed business plans outlining biotechnology activities, shareholder credentials and qualifications, facility layout designs for laboratory or manufacturing operations, and proof of technical expertise relevant to the chosen business activities.

For companies involved in clinical research or pharmaceutical development, additional documentation may include research protocols, ethics committee approvals, and detailed safety management plans that align with EDE requirements and international best practices.

Corporate shareholders must provide attested memorandums of association, board resolutions authorizing the Dubai establishment, and certificates of good standing from their home jurisdictions. Individual shareholders require passport copies, curriculum vitae highlighting relevant experience, and professional qualification certifications.

2. Step-by-Step Registration Process

The company formation process begins with trade name reservation and initial approval, typically completed within 3-5 days of submission. 

Following name approval, companies submit comprehensive incorporation documentation to the relevant free zone authority, with review periods ranging from 1-2 weeks depending on business complexity and regulatory requirements.

Upon documentary approval, companies receive preliminary business licenses that authorize facility selection and lease agreement execution. The final licensing phase requires submission of signed lease agreements, payment of all applicable fees, and completion of any zone-specific requirements such as facility inspections or regulatory approvals.

Bank account opening represents the final major milestone in the incorporation process, typically requiring 1-2 weeks to complete once all corporate documentation is finalized and submitted to approved banking partners.

3. Timeline Considerations and Facility Requirements

Standard biotech company incorporation without specialized laboratory requirements can be completed within 4-6 weeks from initial application to final license issuance. 

However, companies requiring laboratory fit-outs, specialized equipment installations, or regulatory approvals for controlled substances may require 2-4 months to achieve full operational status.

Laboratory-based operations must comply with stringent biosafety requirements, including proper ventilation systems, chemical storage protocols, waste disposal arrangements, and emergency response capabilities.

Companies planning laboratory operations should engage regulatory consultants early in the planning process to ensure facility designs meet both free zone requirements and EDE regulatory standards.

Cost Breakdown and Financial Planning

1. Initial Setup Costs and Capital Requirements

Biotech company setup costs in Dubai vary significantly based on business scope, facility requirements, and chosen free zone. Dubai Science Park company registration packages start at approximately AED 50,290, including basic incorporation, a trade license, and flexi-desk office accommodation.

Companies requiring dedicated laboratory space should budget AED 160-200 per square foot annually for shared or private laboratory facilities within DSP. Office accommodations range from AED 25,000 annually for basic office space to AED 60,000 for premium locations with enhanced amenities.

JAFZA warehouse facilities, suitable for pharmaceutical storage and distribution operations, are available from AED 400 per square meter annually, with industrial manufacturing spaces commanding premium rates based on specific facility requirements and utility needs.

2. Operational Expenses and Regulatory Costs

Annual operational expenses for biotech companies include trade license renewals, establishment card fees, visa processing costs, and mandatory audit requirements starting from the second year of operations. 

Companies engaged in pharmaceutical activities face additional regulatory costs, including EDE licensing fees, import permit charges, and periodic inspection fees.

Clinical trial approvals through MOHAP require application fees of AED 100, while pharmaceutical facility licensing commands AED 50,000 annually for final approvals. 

Companies importing pharmaceutical raw materials or finished products pay 1% of invoice value for import permits, with minimum fees of AED 200 per invoice.

Funding and Financial Support Programs

The UAE government provides substantial financial support for biotech innovation through various federal and emirate-level initiatives. 

The Sheikh Mohammed bin Rashid Al Maktoum Fund for Innovation offers financing solutions prioritizing healthcare, technology, and renewable energy sectors, with particular focus on companies demonstrating innovative approaches to healthcare challenges.

Abu Dhabi’s HELM cluster initiative, projected to contribute AED 94 billion to GDP by 2045, includes dedicated funding mechanisms for biotech startups and established companies expanding their operations in the UAE. 

The cluster initiative encompasses direct investment opportunities, grant programs, and public-private partnership frameworks designed to accelerate biotech innovation and commercialization.

Dubai Science Park Facilities and Infrastructure

Dubai Science Park provides comprehensive laboratory infrastructure, including wet labs, dry labs, and specialized research facilities equipped with compressed gas lines, vacuum systems, and sophisticated waste management capabilities. The park’s LEED-certified buildings offer energy-efficient operations while maintaining the environmental controls necessary for sensitive biotech research and development activities.

Shared laboratory spaces enable startup companies to access advanced research capabilities without significant capital investment, while custom laboratory shells allow established companies to create specialized facilities tailored to their specific research requirements. The park’s infrastructure includes dedicated areas for cell culture, molecular biology, analytical chemistry, and biotechnology production at pilot scale.

Financial Support Programs and Government Initiatives

1. Federal Innovation Funding

The UAE’s commitment to biotechnology innovation extends through comprehensive funding mechanisms designed to support companies at all stages of development. 

Federal initiatives include the National Innovation Strategy framework, which allocates substantial resources to healthcare and life sciences innovation, and Operation 300Bn, the industrial strategy targeting AED 300 billion in economic impact over five years.

These programs provide direct financial support through grants, subsidized loans, and investment partnerships that enable biotech companies to scale their operations while contributing to the UAE’s strategic objective of building a knowledge-based economy centered on innovation and technological advancement.

2. Abu Dhabi Healthcare Research and Innovation Grants

The Abu Dhabi Healthcare Research and Innovation Grant program offers targeted funding for biotech research projects that address regional healthcare challenges and contribute to the global advancement of medical science. This program supports both academic research institutions and commercial biotech companies conducting clinically relevant research within the UAE.

Grant recipients benefit from direct financial support, access to clinical research facilities, and collaboration opportunities with leading healthcare institutions throughout the Emirates. The program particularly emphasizes personalized medicine, genomics research, and innovative therapeutic development that aligns with the UAE’s national health priorities.

3. Incubator and Accelerator Programs

Dubai and Abu Dhabi host several world-class incubator programs specifically designed to support biotech startups and emerging companies. 

The startAD HealthX program provides comprehensive support, including funding, mentorship, and market access opportunities for companies developing healthcare and biotechnology solutions.

Hub71 in Abu Dhabi offers substantial support for technology startups, including biotech companies leveraging artificial intelligence, machine learning, and digital health platforms. The program provides funding, office space, visa support, and access to a network of international investors specializing in healthcare and life sciences ventures.

These programs recognize that biotech companies require longer development timelines and greater capital intensity than traditional technology startups, offering flexible support structures and patient capital that enable companies to achieve regulatory milestones and clinical validation before pursuing commercial scale-up.

FAQs

1. Who regulates biotech and pharmaceuticals in the UAE in 2025?

The Emirates Drug Establishment (EDE) is the federal regulator for medical products, pharmacies, and pharmaceutical establishments, with Federal Decree‑Law 38/2024 in force from 2 January 2025.

2. Is there a grace period to comply with the new law?

Yes. Entities covered by Federal Decree‑Law 38/2024 have a one‑year grace period from 2 January 2025 to align with its provisions, extendable by Cabinet decision.

3. Do the old executive regulations still apply?

Yes, the executive regulations of the 2019 framework continue to apply where they do not conflict with Federal Decree‑Law 38/2024 until new regulations are issued.

4. What are EDE’s core responsibilities?

EDE oversees marketing authorizations, import/export permits, licensing, pharmacovigilance, and inspections and will maintain a UAE pharmacopoeia and traceability systems.

5. Which Dubai free zones are most relevant for biotech?

Dubai Science Park (DSP) for labs and R&D; JAFZA for manufacturing and distribution; DHCC for clinical/medical integration; DMCC for pharma commodities trading.

6. What’s the current status of Dubai Science Park (DSP)?

DSP (formerly DuBiotech) is an established life sciences hub launched in 2005, housing 400+ companies and providing specialized lab and business infrastructure.

7. How do I get approval for clinical studies of drugs?

Apply through MOHAP’s service for assessment and approval of medical products for pharmacological research and clinical studies before commencing any trial.

Taking Action 

The combination of government funding, private investment, and institutional support creates a comprehensive ecosystem that enables biotech entrepreneurs to establish, develop, and scale their operations in Dubai.

Dubai’s biotechnology ecosystem represents one of the world’s most compelling opportunities for life sciences entrepreneurs and established companies seeking regional expansion. 

The convergence of strategic government support, world-class infrastructure, streamlined regulatory frameworks, and substantial financial incentives creates an environment where biotech innovation can flourish and scale to serve global markets.

Book your Free Consultation call today with the expert of JSB Incorporation to learn more about setting up your biotech company in Dubai.