CGT & Biotech
“Innovate. Scale. Transform.”
- 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.
- 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.
- 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.
- 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.
MedTech
“Enter. Commercialize. Localize. In Saudi Arabia”
- 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.
- 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.
- 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.
Analytical CROs & R&D
“Develop. Validate. Assure.”
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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.
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Method Development, Validation & Verification: Tailored design, optimization, and verification of analytical methods to global standards—accelerating product development and regulatory approvals.
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Analytical Technology Transfer Support: Seamless transfer of validated methods and processes between sites or partners, minimizing risk and ensuring continuity of quality and compliance.
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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.


