“Innovate. Scale. Transform.”

1. Regulatory Strategy & Risk Analysis: End-to-end guidance through SFDA approval pathways for Cell & Gene Therapy (CGT), ATMPs, mRNA, stem cell products, and other advanced biotechnologies—ensuring compliance, risk mitigation, and accelerated market entry.
2. Advanced Manufacturing & Technology Transfer Support: Comprehensive support for scale-up, tech transfer, and quality compliance to global standards, enabling smooth transition from development to large-scale production.
3. GMP Facility & Cleanroom Solutions: Design, build, and operationalize GMP-compliant cleanrooms, analytical and quality-control labs, and mobile GMP facilities—offering full project implementation support to meet SFDA requirements.
4. Localization & End-to-End Bio-Manufacturing Solutions: Expertise in establishing and operating biotechnology and advanced therapy manufacturing facilities in Saudi Arabia. From regulatory approvals to workforce development, administrative support, and public/private funding facilitation, we help partners localize their operations while achieving international benchmarks.

“Enter. Commercialize. Localize. In Saudi Arabia”

1. Saudi FDA Market Access & End-to-end Saudi FDA Regulatory Guidance:  End-to-end guidance on Saudi FDA registration and compliance to accelerate your time-to-market.
2. Strategic Matchmaking for Commercial Execution: Tailored matchmaking across the Saudi healthcare value chain, facilitating strategic partnerships with sales channels (e.g. distributors, retailers), institutional stakeholders, and public procurement authorities to accelerate commercialization. 
3. Localization in Saudi Arabia: Comprehensive support to localize your operations, manufacturing, R&D facilities, and clinical trials, while streamlining administrative and legal processes and securing public/private fundings to scale your MedTech innovation in Saudi Arabia.

1. Regulatory & Compliance Consulting: Comprehensive support to ensure your analytical and R&D activities meet Saudi and international regulatory requirements for biologics, cosmetics, and advanced therapies.
2. Method Development, Validation & Verification: Tailored design, optimization, and verification of analytical methods to global standards—accelerating product development and regulatory approvals.
3. Analytical Technology Transfer Support: Seamless transfer of validated methods and processes between sites or partners, minimizing risk and ensuring continuity of quality and compliance.
4. Quality & Contract Testing Services: High-precision analytical and quality control testing for biologics, cosmetics, and other high-critical products, acting as an extension of your R&D and QC teams.