Pharmaceutical Innovation Services S.L.

Your end-to-end R&D team

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