Dossier Gap Analysis

The pathway required to bring a new therapeutic product to market can be complex, so in addition to strategic development, Accelagen also detailed analysis of the regulatory dossier to identify any areas requiring enhancement as a means to reduce risk. Using our industry insights and vast experience, we identify any potential gaps in the implementation of your strategy, aligning with best practice standards, guidelines and regulatory protocols across selected countries and jurisdictions. The outcome is a comprehensive summary of any observations as part of the Regulatory Development Strategy and a series of proposed steps to mitigate these risks effectively.

What this includes:

• Preparation of Drug Development Plans
• Pre-clinical vendor selection and management
• Scientific Advice
• Therapeutic Area Advice
• Chemistry Manufacturing Controls (CMC) Advice
• Preparation of Investigator’s Brochure
• Regulatory agency submission support
• Medical writing services