About
CRAI Consulting was founded in Dubai by Ram Vangala, who has spent more than 17 years taking medicines into markets in the Middle East, Africa and beyond, first inside large pharmaceutical companies and now as an independent adviser. We keep the team small on purpose, because the work we take on depends on the people doing it, and the companies and partners we work with know exactly who will be handling their product.
Ram Vangala, Founder
I get medicines approved where no pathway exists yet.
Ram has spent his whole career getting medicines approved in markets where the route is rarely written down, starting in 2009 as a CMC writer at Novartis in Hyderabad, where he prepared dossiers for international markets and led production transfers and site divestments, before moving to Dubai in 2012 to run regulatory work for the Gulf. Over the next ten years he grew from Gulf regulatory manager into head of regulatory operational excellence and compliance for the Middle East and Africa, contributing to more than 50 innovative therapy approvals across the region, including the first CAR-T approvals in Saudi Arabia and the UAE, leading the regional labelling and CMC teams, and running PV and regulatory audits and inspection readiness with no critical findings.
Alongside the regional role he led regulatory affairs locally in Saudi Arabia in 2017 and in Algeria from 2019 to 2020, ran the regional side of the acquisition of oncology and ophthalmology portfolios and the divestment of an OTC portfolio, which together moved more than 20 products across the region, and in 2021 worked as global program regulatory manager for advanced therapies covering the EU and international markets including Brazil, Singapore and South Korea.
In 2022 he joined Kite, Gilead’s cell therapy company, as associate director for cell therapy programs, where he led the pre-submission meetings with the SFDA and the accelerated filings that brought the second CAR-T therapy to patients in Saudi Arabia and the UAE, and worked with hospitals and the supply team on treatment centre readiness and with the SFDA on the product’s risk management programme.
From 2023 to 2025 he built and ran his own market-entry business in Dubai, which gave him a commercial view of launches that most regulatory people never get, because he saw first-hand what a distributor needs to make a product work, how a pricing decision plays out once the product is on the market and how getting paid shapes what a company can actually do. That experience is why he treats regulatory work as the way to get a product to patients and to revenue sooner.
He has also represented industry in regional trade associations and authority working groups, contributing to the discussions behind accelerated approvals, eCTD and labelling modernisation in the region.
Bachelor of Pharmacy (Hons), BITS Pilani. MSc Clinical Research and Regulatory Affairs. GxP auditor certified. Six Sigma Black Belt. Novartis Global Excellence Award.
Ram on LinkedIn
Selected work
Experience of the founder in previous roles unless marked current. Products are described by type.
The first two CAR-T approvals in the UAE and Saudi Arabia
Worked on the first CAR-T approval in both markets, where early engagement with reviewers assessing a CAR-T for the first time brought approval in roughly two months in the UAE and around six in Saudi Arabia, then led the regulatory route for the second CAR-T into the UAE, Saudi Arabia and Kuwait under the abridged review procedure, which relies on EU and US assessment reports. With dedicated ATMP guidelines now in place in Saudi Arabia, we plan for reviews closer to 12 months there today.
Treatment centre activation
Brought around six hospitals from first contact to ready to treat, working through site qualification, chain of identity, apheresis and the movement of cells out and finished product back, so the first patients were treated without gaps in the process.
Risk management for a CAR-T in Saudi Arabia
Agreed a product-specific risk management plan with the SFDA and rolled out the measures it required: patient alert cards, caregiver training, CRS and ICANS guidance for treating teams, and long-term follow-up reporting.
Health authority readiness in Israel, Singapore, South Korea and Brazil
Worked with local regulatory teams preparing cell therapy submissions on strategy, the questions to expect from their authority, and drafting responses during review.
Regional integration of acquired and divested portfolios
Managed the regional side of two portfolio acquisitions and one divestment, more than 20 products across the Middle East and North Africa, so licences moved to the right holder without interrupting supply.
Bringing innovative medicines into the region
From 2011 to 2019, moved from hands-on regulatory work on new launches to setting regional strategy for them across oncology, immunology, respiratory, dermatology, anti-infectives and transplant, and assessed the price impact of site changes before they went ahead.
Regulatory intelligence and compliance
Assessed every new regulatory and PV guideline across the region for its impact on the portfolio, wrote the SOPs to meet new requirements, and led the regional rollout of a regulatory information management system.
Current: cell therapy in Turkey and the region
Supporting an established cell therapy company in a six-month project covering Turkey and the wider region.