Regulatory Services

MPCC provides Regulatory Affairs Services to all clients in Pharmaceuticals and assist them at each step of the specific regulatory process to manage their timely launch of pharmaceuticals in the Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, Oman, and centrally in Gulf Cooperation Council (GCC), Jordan, Iraq and Egypt.

MPCC Available Regulatory Affairs Services

Promotional and Educational Material

• Check Health Care Educational Material according to SFDA regulation.
• Check Patient Educational Material according to SFDA regulation.
• Get SFDA approval for Patient Educational Material.
• Check promotional material for Human drug according to SFDA regulation.
• Get SFDA approval Get SFDA approval promotional material.

Human Drug, Health or Herbal, and Veterinary Registration Services

• Drug Evaluation and prepare the requirements for submissions and conversion as CTD, NeeS and eCTD format based on authorities’ requirements and regulations.
• Objection for Registration
• Price Appeals
• Migration, Baseline, Renewal & Variation
• Follow up registration, Migration, Baseline and renewal.
• Prepare and review Artworks, Leaflet, SPC based on authorities' requirements and regulations.
• Prepare RMP and PSUR based on authorities’ requirements and regulations.
• Submit product information to SDI.
• Pricing and Economic Studies Consultation

 Issue Importing and Clearance Permission of Pharmaceutical Shipment to KSA Manufacturer

• Registration
• Renewal
• GMP and Inspection Consultation
•  Consultation regarding Technology Transfer /Contract manufacturing
• Add Bioequivalence Center to Gulf Cooperation Council (GCC) List