eCTD-PHARMA (abstract)

eCTD-PHARMA is a modern and innovative software for the design, implementation and electronic submission of Dossier of Medicinal Products, according to the organisational models defined by the CTD/eCTD Standard, and for the subsequent management of its Life Cycle. With equivalent completeness and effectiveness also applies to the production of active substances for the Drug Master File.

This is the management system for a Regulatory Compliance structure that operates in a complex organizational context, and which must govern an articulated portfolio of registration dossiers. It’s oriented to project management of complex and articulated phases, allows on-line the project manager to create the content management structure of the dossier in preparation, and to define the plan and the access scheme for data security during the implementation phase.

With the workflow that the system has, the project manager can coordinate the activities that will be carried out for competence by the various specialists, internal and/ or external to the company, and ensure compliance with all stages of the development plan until the dossier is submitted to the competent authority.

The planning, management and control functions available at the first submission stage shall, as appropriate, be made available at the subsequent update stages of the dossier in relation to natural variations in the reference product, hence the possibility of managing its Life Cycle.

eCTD-PHARMA has been developed with the collaboration of specialists working in the regulatory field, resulting in a constantly careful design to meet the most refined application needs, entrusting the system with the correct interpretation of the complex technical regulations to allow the user to concentrate exclusively on the professional content of his role.

The result is a tool of large application size, yet easy to insert into the company and easy to use.

This allows the organisation to achieve its objectives without creating new structures or committing additional resources, given the certainty that the investment can be assessed exclusively on the basis of published prices and the guarantee that it does not need to incur additional consultancy or assistance costs.