GMP & ISO Certified Quality Solutions For Life Science Industries
Building Reliable Quality Infrastructure
GMP and ISO-focused quality services tailored for pharmaceutical, biotech, and MedTech companies operating in Saudi Arabia. Services include designing compliant Quality Management Systems (QMS), supporting GMP readiness, conducting internal audits, and guiding companies toward ISO 13485 certification through IAF-accredited partners. Certified training programs and inspection preparation ensure teams are fully equipped to meet SFDA and international standards. Whether launching new operations or strengthening existing ones, our quality services help ensure compliance, operational efficiency, and long-term regulatory success.
Trusted Certification
Local Insight
Proven Compliance
Regulatory Expertise
Inspected Like SFDA Would
GMP Compliance
We support pharmaceutical and biotech companies in achieving and maintaining Good Manufacturing Practice (GMP) compliance for new and existing facilities. Our team includes former SFDA inspectors who perform detailed pre-audit visits, identify gaps, and help your teams prepare for official inspections. We also assist with responding to SFDA findings and implementing CAPAs effectively.
Our services include:
- GMP gap assessments and readiness reviews
- Mock inspections by former regulators (Pre-Audit)
- SFDA-style audit reports and remediation plans
- Coaching on how to handle SFDA inspections
- CAPA drafting and closure support
Trusted, Recognized Certification
ISO Certification
We support manufacturers, warehouses, and authorised representatives in achieving ISO certification recognised and accepted by SFDA. Our certifications are issued through IAF-accredited bodies and meet international quality standards. We’ve helped hundreds of local entities obtain certification with efficient, audit-ready systems.
We provide:
- Gap assessment and ISO documentation support
- Fast-track certification planning and execution
- IAF-accredited certification issuance
- Ongoing support for post-certification maintenance
- Proven track record across diverse MedTech operations
Structured. Compliant. Reliable.
Quality Management System (QMS)
We design and implement customised Quality Management Systems (QMS) for pharmaceutical, biotech, and MedTech companies in Saudi Arabia. Our solutions cover manufacturers, warehouses, scientific offices, pharmacovigilance operations, and authorised representatives. Each system is built to align with SFDA expectations and international standards, ensuring audit readiness and operational efficiency.
We deliver:
- Complete QMS design from scratch
- SOP development and document control systems
- Role-specific workflows and responsibilities
- System integration with existing quality tools
- Hands-on guidance during implementation
Empowering Quality Teams
Quality Training & Qualification
We provide practical training programs for pharma and medical device professionals focused on operating QMS, internal auditing, and meeting regulatory requirements. Our courses are designed for real-world implementation and can be tailored to your operations. We also offer internationally accredited certificates for internal auditors, certified by IAF-accredited bodies.
Our training covers:
- QMS operations and best practices
- Internal audit training with IAF-accredited certification
- GMP, GDP, and ISO standards compliance
- Customized sessions for QPs, QA, and warehouse teams
- On-site or remote delivery options
