Diagnostics
As Saudi Arabia accelerates its life sciences development under Vision 2030, aligning local research and manufacturing practices with global regulatory frameworks has become essential. Ariba & Mac Limited plays a key role in this evolution, connecting scientific innovation with international compliance standards that ensure safety, efficacy, and trust.
Our regulatory specialists work closely with global and regional agencies — including the SFDA, MENA, EMEA, FDA, GHC, DRAP, MHRA, and EMA — to help organizations streamline submissions, validate data, and implement Good Manufacturing and Clinical Practices (GMP, GCP, GLP). By bridging research and regulation, we make innovation market-ready.
“Compliance is not bureaucracy — it’s the language of global trust. Saudi biotech can only achieve its full potential by speaking it fluently.”
— Regulatory Affairs Director, Ariba & Mac Limited
From Research Bench to Regulatory Benchmarks
Translating laboratory discoveries into licensed therapies demands precision, documentation, and alignment with international norms. Our teams guide partners through every stage — from pre-clinical research to clinical trials and dossier submission — ensuring each milestone meets the quality expectations of global markets.
- Developing ICH-compliant technical documentation and eCTD submissions.
- Ensuring product lifecycle compliance across pre-approval and post-market stages.
- Training research teams in Good Laboratory Practice (GLP) and data integrity principles.
- Supporting SFDA registration for local and imported pharmaceuticals.
Strengthening Saudi Arabia’s Regulatory Ecosystem
Our contribution goes beyond consultancy — we are building capacity. By mentoring Saudi regulatory professionals and collaborating with public health authorities, we strengthen the local system’s ability to evaluate and approve world-class biopharmaceutical products.
We work to harmonize global standards with regional realities — ensuring that Saudi companies can innovate with confidence while maintaining full alignment with international expectations. This integrated approach fosters both safety and competitiveness.
Compliance as a Catalyst for Innovation
At Ariba & Mac, we see compliance not as a limitation but as an enabler. Every well-documented trial, validated dataset, and successful regulatory submission accelerates innovation. Through disciplined regulatory alignment, Saudi biotech is earning a seat at the global table — not just as a participant, but as a leader shaping the future of healthcare.