Dossier Audit Service

Dossier writing is considered a valuable skill, while dossier reading is often regarded as an intricate art form. It is common for pharmaceutical manufacturers to have their own regulatory affairs departments, although it is not always a requirement for regulatory professionals to possess extensive knowledge about various processes. It has been observed that there tends to be a lack of strong coordination between the quality assurance (QA) and regulatory affairs departments. It is essential that a dossier, once prepared by a regulatory professional, undergoes thorough review prior to its submission to any authority. This is crucial because even minor mistakes can result in significant losses or outright rejection of the dossier. For instance, if a regulatory professional inadvertently includes the wrong ingredient specification in the documentation due to time constraints, it cannot be easily rectified or reevaluated once it has been submitted. Another potential error involves the audit of process documents, such as ensuring proper alignment between the Process Development Report (PDR) and the manufacturing process, or verifying consistency between specifications and the unit formula. These examples shed light on the potential errors that can occur during the process of dossier writing.

In CPPL, our technocrats take care of reviewing dossiers with their thorough knowledge of the process and analytical documents. They provide comments to your team for corrections. An audit of the dossier is necessary nowadays because if the wrong or inadequate dossier is submitted, it will lead to wasted time and money. Sometimes, it may even result in the rejection of the dossier. To avoid this, CPPL recommends auditing dossiers before submission. This way, we can provide you with the best regulatory consultancy services. Cyclone Pharmaceuticals' services are proven to have the highest quality and lowest cost. Our compiled documents have been accepted many times by regulatory authorities without any queries. The CPPL team is always alert for new updates in regulations and provides perfect drug dossiers in various formats such as DMF, CTD, ACTD, KDMF, USDMF, eCTD, EUDMF, and USDMF.

Dossier Audit is necessary :

1. To avoid future queries.
2. To save time and money.
3. To understand and evaluate functioning of your regulatory team.
4. To get perfection in Dossiers.