SFDA Consultants, Regulatory, and Registration Services in Saudi Arabia
Leverage Our Regulatory Strategies...
Supporting Live Science Industries To Overcome Regulatory And Compliance Challenges In Saudi Arabia
New Market Entry
We design and implement SFDA regulatory projects and Saudi market supply strategies from global manufacturers to the Saudi market, including securing necessary SFDA approvals.
Marketing 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.
Post Market Surveillance
Our safety and Pharmacovigilance staff fully comply with the regulatory requirements for safety monitoring through our robust vigilance systems for pharma, medical devices, and cosmetics.
Welcome
“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…”
CEO, Consultant
Our Clients
Our Services
Regulatory Affairs
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.
Pharmacovigilance
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.
SFDA Consulting
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.
Commercial Support
Since 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.
Authorized Representative
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.
SFDA Registration
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.
Industries We support
Pharmaceuticals
Pharmaceuticals
Supplements
Health & Herbals
Medical Devices
Medical Devices
Cosmetics
Cosmetics
Veterinary
Veterinary
Why PharmaKnowl
Credibility
Licensed by SFDA & MOC
Quality
Iso 9001:2015 Certified
Continuity
Business Continuity Measures
Privacy
Data Privacy / Protected Servers
Knowledge
Updated with the latest regulations and related market dynamics information to provide solid opinion and regulatory intelligence.
Cross-Sector Experience
Equipped with SFDA and industry experience, providing insights for planning, decision making, and strategy.
Qualified Staff
Licensed pharmacists and biotechnologists with deep regulatory experience in various types of products and life science industries.
Credibility
We are trusted by top 10 pharma and biotech companies—a local partner of global leading consulting firms.
Insights
Medical Device Authorized Representative (SFDA AR)
SFDA Cosmetics Regulations & Registration (eCosma)
SFDA Drug Registration Requirements
SFDA Medical Device Registration
SFDA Registration Requirements
SFDA GMP: Manufacturer Registration in Saudi Arabia
Latest Insights
Announcement: Signal Management Workshop (March 2023 Riyadh)
PSUR report: SFDA requirements of submission (Saudi Arabia)
