SFDA Regulatory Services

Nakhal Consulting provides specialized consulting services to support pharmaceutical and healthcare companies in navigating Saudi Food and Drug Authority (SFDA) regulatory requirements.

We assist companies in understanding local regulations and preparing high-quality submissions to ensure efficient product registration in Saudi Arabia.

Our SFDA services include:

• SFDA product registration support
  Guidance through the full registration process for pharmaceutical products.

• CTD and eCTD dossier preparation
  Preparation, compilation, and review of regulatory dossiers in accordance with SFDA requirements.

• Regulatory strategy for Saudi market entry
  Advisory services for international companies planning to introduce products into the Saudi market.

• Support in responding to SFDA inquiries
  Assistance in preparing responses to SFDA questions, deficiencies, and regulatory comments.

• Variation and lifecycle management
  Support in post-approval changes, variations, and regulatory lifecycle activities.

• SFDA compliance consulting
  Guidance on compliance with Saudi regulatory requirements and guidelines.