Certified Regulatory Partner in Saudi Arabia for Pharmaceutical and MedTech Companies
in Saudi Arabia
We design and implement SFDA regulatory projects and Saudi market supply strategies from global manufacturers to the Saudi market, including securing necessary SFDA approvals.
Our SFDA consultants provide and execute registration plans in Saudi Arabia to secure product approvals and licenses to allow fast access and smooth clearance of goods into the market.
Our safety and Pharmacovigilance dept enhance compliance with the regulatory requirements for safety monitoring through our robust vigilance systems for pharma, medical devices, and cosmetics.
For us, there is nothing more satisfying than achieving a regulatory milestone, especially marketing approvals.
This feeling repeats itself whenever we encounter a product that
we had licensed in the market.
We're looking forward to working with you on creating yet another success story…
Consultant, Founder
Our SFDA consultants will design and implement innovative & visionary regulatory strategies to support your business. Providing product registration services, marketing approvals, new market entry projects, MA transfers, licensing, local manufacturing, and life cycle management.
Managing your pharmacovigilance function and post-marketing activities in Saudi Arabia, including QPPV Outsourcing, PV System, Development of PSMF / PSSF, Local literature monitoring, PV audits, and Training.
Empower your decision-making by utilizing our experience in SFDA consultations, Saudi market research, and our insightful regulatory opinion. We guide, plan, and implement your regulatory projects in the Saudi Arabia market.
OSince commercial and marketing modules vary in the Saudi market, directly impacting profit margins, we support the new access for international companies with insights and SWOT analysis on all available trade pathways.
We represent international biotech and medical device companies in Saudi Arabia. Providing full compliance with SFDA regulations, maintaining approvals, and post-marketing safety case submissions.
Leverage our advanced due diligence and gap
analysis methods for your product files to achieve SFDA approval.
Our consultants are experts
in product registrations, including drugs, biologicals, medical devices, food supplements,
and others.
Innovative, biological, biosimilars, vaccines, and generic medicines.
Herbal and health products and nutritional supplements.
Medical devices, supplies, equipment, and technologies.
Cosmetic, makeup, hygiene, and Beauty Products.
Veterinary medicines, vaccines, products,and pesticides.
Licensedby SFDA & MOC.
ISO 9001:2015Certified.
Business ContinuityMeasures
Data PrivacyProtected Servers
Updated with the latest regulations and related market dynamics information to provide solid opinion and regulatory intelligence.
Equipped with SFDA and industry experience, providing insights for planning, decision making, and strategy.
Licensed pharmacists and biotechnologists with deep regulatory experience in various types of products and life science industries.
We are trusted by top 10 pharma and biotech companies a local partner of global leading consulting firms.
