When publishing a dossier, life sciences companies typically struggle with efficiently compiling supporting documentation. Usually, this is the result of dealing with paper and electronic documents, legacy versions and incomplete or inaccurate data due to human error. This does not need to be the case. To prevent documentation from becoming a costly issue, companies can take steps (on the front end and throughout the entire document lifecycle) to enable a smooth submission process.
Document management is nothing new to regulatory affairs professionals. Long before the Food and Drug Administration (FDA) and other regulatory bodies began developing their first guidance for submission format and content, regulatory affairs professionals had to contend with the challenges of gathering and managing documents from disparate functional groups including clinical, non-clinical, manufacturing and drug safety. This information then had to be organized to facilitate the bidirectional exchange of information between the applicants and regulatory agencies to meet guidelines such as those imposed for an Investigational New Drug Application (IND) or a New Drug Application (NDA).
For both industry and regulators, the implementation of submission formatting standards was a welcome relief from the previous ad hoc submission process. Still, there remained a “disconnect” between the content and documents generated by the functional areas and what was eventually submitted to the regulatory bodies.
As most regulatory affairs professionals know, from the time the investigational applicationâ€” such as an INDâ€”is submitted until the time when the marketing application is finally filed, often hundreds of amendments are filed and submitted. This makes it difficult both for the reviewer, who must at any given moment be sure what the product’s current and effective information is, and the sponsor, who must manage the previous information that was submitted and the reasons for each amendment.