Regulatory Affairs

• Advice on the regulatory strategy of the product.
• Assistance to request Scientific Advice from Health Authorities 
  
• Evaluation and preparation of dossiers.
• Assessment of variations to the dossier. 
• Support on defficiency letters. 
• Preparation of pre-clinical and clinical sections  
• Preparation of Investigational Medicinal Product Dossiers (IMPDs)
• Readability tests. 
• Preparation of documentation for the application for registration of the company as Marketing Authorization Holder: 

        - Development and design of the Quality Manual
        - Preparation of the MAH Technical Report
        - Preparation of Quality System SOPs and associated record sheets

• Advice and technical support to adapt your company to good distribution practices (GPD): Support, advice and preparation of all marketing authorisation holder (MAH) documentation until obtaining the Authorization and GDP Certificate