The SFDA is the primary regulatory body in Saudi Arabia responsible for ensuring the safety, efficacy, and quality of medical devices, pharmaceuticals, and cosmetics. The SFDA sets stringent standards to protect public health and facilitate market access for innovative products.
Our services in KSA for Pharmaceuticals:
The authority oversees the registration and monitoring of pharmaceutical products, enforcing compliance with rigorous testing and approval processes to ensure drug safety and efficacy., the process done through eSDR portal.
Comprehensive Regulatory Assessments:
In-depth evaluations of pharmaceutical products in compliance with Saudi regulations.
Product Registration, Variation, and Renewal:
- New Registration:
Initial product classification and eligibility assessment.
Preparation and submission of required documentation.
Liaison with the Saudi Food and Drug Authority (SFDA) for application processing.
- Variation Process:
Guidance on changes to product formulations or packaging.
Ensuring compliance with updated regulatory requirements.
- Renewal Procedures:
Timely identification and initiation of product renewal.
Compilation and submission of necessary renewal documents.
- Regulatory Updates:
Keeping clients informed about changes in Saudi Arabian pharmaceutical regulations.
Proactive measures to adapt products to evolving regulatory standards.
- General Pharmaceutical Consultations:
Expert advice on various regulatory and compliance issues within the pharmaceutical sector.
- Market Authorization Strategy:
Developing strategic plans for market entry and positioning of pharmaceutical products in Saudi Arabia
- Regulatory Intelligence:
Providing insights into emerging regulatory trends and their potential impact on pharmaceutical products.
- Labeling and Packaging Compliance:
Ensuring that product labels and packaging meet all regulatory requirements and guidelines.
- Crisis Management and Regulatory Support:
Providing support in the event of regulatory issues or product recalls, including developing and implementing corrective action plans.