Before a pharmaceutical product can be placed on the market, a complete technical dossier must be submitted to the regulatory authorities, containing all the information required to demonstrate its quality, safety and efficacy. The Documentation team plays a vital role throughout this process, coordinating the preparation, management and updating of documentation relating to products under development, and so ensuring compliance with regulatory requirements.
The team’s work spans the entire medicine development cycle and acts as the link between the scientific evidence generated by research work and the Regulatory Affairs department, helping to ensure that the authorisation process is robust, consistent and compliant.
The research facilities and laboratories are also subject to periodic inspections by the competent authorities. These inspections cover research and development activities as well as industrial operations and are designed to verify compliance with the international standards governing the development and manufacture of medicines, including specifically Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).