Quality Assurance & Regulatory Affair

We offer a complete spectrum of comprehensive regulatory services, consulting and intelligence services including:

• Assist with due diligence activities for investors/licensees
• Dossier/submission preparation or review and filing
• Development of regulatory strategy for the product’s life cycle
• Consideration of international regulatory requirements
• Meeting international filings
• Revision of plans as guidelines change
• Facilitate interaction with regulatory agencies, negotiations during, submissions and submission approval process
• Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical and toxicology matters
• Regulatory classification of products across different jurisdictions
• Provide expert Regulatory Compliance advice
• Act as Local Technical Representative for Kenyan submissions