Regulatory Affairs & Regulatory Intelligence

We are your trusted guide through the intricate world of product registration. Our services encompass the entire process, from initial concept to post-market support.

• Unparalleled Expertise: We boast over 20 years of experience in crafting successful regulatory strategies.
• Customized Solutions: Our team meticulously tailors its approach to find the fastest and most cost-effective registration path for each client.
• Proven Track Record: Our success is built on a commitment to quality, compliance, and cutting-edge technologies.

Lariox Regulatory Affairs Services Includes:

Pre-registration

• Product Assessment Thorough evaluation of your product to ensure compliance with Egyptian regulatory requirements and international standards
• Regulatory Landscape Analysis In-depth assessment of the regulatory framework relevant to your product, including applicable laws, regulations, and guidelines
• Gap Analysis Identification of any discrepancies between your product and regulatory requirements, along with recommendations for compliance
• Documentation Review Verification of the completeness and accuracy of your product's technical and regulatory documentation
• Product Compliance We offer label validation, formula validation, and technical translation services

Registration

• Regulatory Strategy Development Tailored guidance on the most effective registration pathway based on your product's characteristics and target market
• Submission Package Preparation Our team expertly prepares and submits Common Technical Documents (CTDs) to meet all regulatory requirements
• Regulatory Operations Receive ongoing support, including application follow-up, dossier structuring, and MOH communication

Post-registration

• Post-Approval Compliance Ongoing monitoring of regulatory changes and ensuring compliance with post-market requirements
• Labeling and Packaging Review Verification of labeling and packaging accuracy and compliance with local regulations
• Adverse Event Reporting Assistance in establishing an effective adverse event reporting system and timely submission of reports
• Regulatory Updates Provision of regular updates on regulatory changes and their implications for your product
• Market Authorization Management We handle Market Authorization Transfers (MATs), CMC variations, and renewals
• Labeling & Artwork Services Ensure regulatory compliance with safety data review, artwork review, and label/leaflet creation
• Product Life Cycle Management Guidance on managing changes to your product throughout its lifecycle, including variations and CMC updates
• Promotional Material Review We ensure your promotional materials comply with regulations before publication