Regulatory Affairs Services

Biologics and Vaccines:

• Regulatory and Scientific Review of drug Dossier.

• eCTD File Preparation.

• Fill the Pharmaceutical Drug Application Form and Dossier submission at SDR.

• Consultations related to Major and Minor Variations of Registered Drugs or Vaccines.

• Renewal and Update of the Drug File within Saudi FDA.

• Mock-inspection of Manufacturing Sites and SFDA Registration.

• Consultations related to Pricing and Re-Pricing.

Pharmaceutical Drug:

• Regulatory and Scientific Review for the Dossier.

• eCTD File Preparation.

• Fill the Pharmaceutical Drug Application Form and Dossier submission at SDR.

• Consultations related to Major and Minor Variations of Registered Drugs.

• Renewal and Update of the Drug File in Saudi FDA.

• Mock-inspection of Manufacturing Sites and drug Registration.

• Consultations related to Pricing and Re-Pricing

Herbal and Supplement Products:

• Regulatory Review for the Dossier.

• CTD File Preparation.

• Fill the Application Form and Dossier submission at SDR.

• Consulting the Major and Minor Variations in the Product.

• Renewal and Updating the Product File in Saudi FDA.

• Registration of Manufacturing Sites.

Cosmetics:

• Listing the Products at E-Cosma System.

• Warehouse Registration.

• Manufacturing Site Registration.