Dossier Gap Analysis.
Adapting your dossier to specific requirements.
Regardless of whether your dossier is already developed, has been recently registered or it is quite old, if you need an extension to the territories it covers, you will need to analyze the content to ensure compliance.
Brief Dossier Gap analysis.
Our consultants can evaluate your existing dossier against local requirements and advise on the step-by-step adaption required to make it suitable to support submission.
Your adapted dossier will be fully compliant with the requirements of the specific market where the application is made, making validation faster, and with far fewer, or no letters of deficiency issued during the evaluation process, resulting in a much faster time to market.
Deep Dossier Gap analysis.
During the lifecycle of your product many changes can occur that impact its registered details such as changing manufacturing sites, changing manufacturing or analytical processes, or raw materials suppliers etc. Regardless of the reason, these changes in combination with the registration and legislation requirements in multiple countries/regions can lead to further complexities and a variety of dossiers for the same product.
If you wish to homogenize or standardize multiple dossiers, or need to ensure compliance between your manufacturing and registered details, or you need to create a fully compliant dossier for future submission, our experts can analyze all of your registration and manufacturing details, and propose a tailored solution and gap analysis report based on a deep understanding of regulatory guidelines and manufacturing processes.