Regulatory Affairs
Pharmacovigilance
Full suite of pharmacovigilance solutions, including Saudi QPPV, safety monitoring, reporting, risk management, and post-marketing compliance.
Quality
Comprehensive services to establish, maintain, and evaluate quality management systems (QMS), GxP compliance, and ISO certification, ensuring regulatory alignment.
Good Manufacturing Practice (GMP)
Expert GMP services supporting facility readiness, audits, validation, qualification, documentation, and compliance with SFDA and global GMP standards.
Saudi Agent Representative
Supporting foreign manufacturers in establishing and operating Scientific Offices in KSA, ensuring SFDA regulatory compliance and effective scientific communication.
Scientific Office
Authorized Saudi Agent Representative supporting compliant product handling, importation, distribution, regulatory representation, and secure storage for market operations in KSA.
Governmental Affairs
Providing strategic regulatory guidance, licensing, approvals, establishment registration, authority engagement, and facilitating market entry in Saudi Arabia.
MORE SERVICES
Strategic Pharma Solutions
Market Access & Research
Delivering actionable market insights to help businesses understand audiences, assess competition, identify growth opportunities, and drive data-informed access strategies.
Creation, Translation & Design
Multilingual translation, artwork creation, and design solutions for packaging and labeling, ensuring culturally adapted content with visual and regulatory compliance.
Contract Manufacturing Organization (CMO)
Flexible, compliant, and reliable contract manufacturing solutions for pharma, from raw material sourcing to final product packaging and distribution.
Bioequivalence
Expert guidance for bioequivalence centers to achieve GCC accreditation and conduct SFDA-compliant bioequivalence studies, ensuring efficient product registration.
Technology Transfer
Facilitate seamless transfer of knowledge, methods, and processes across the drug development lifecycle, ensuring consistent quality, efficiency, and regulatory compliance.
SISTER COMPANIES
Our Group Companies
Bana Medical Co., the holding company leading a group of subsidiaries advancing healthcare and pharmaceutical innovation across the MENA region.
Regional Full-Service CRO with expertise in Phase I–IV Clinical Studies.
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Advanced Public & Customized Training for Pharma & Life Sciences Sector.
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Precision Calibration & Validation for Compliance-Critical Environments.
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Engineering & Turnkey Solutions for GMP Compliance and Regulated Industries.
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