There are several elements to successful regulatory filing summarised in the CTD triangle (below).

  • Pre-clinical/CMC (which includes information from proof of concept to pre-clinical safety and manufacturing quality system).
  • Clinical and post marketing.
  • Labelling (which defines the product indications, contra indications safety notices etc.) and is a process that starts from the point of inception of a bio/pharmaceutical product life cycle and evolves throughout the rest of the product lifetime. 

Although the CTD triangle was developed for bio/pharmaceuticals in fact it is a good representation of all regulatory dossiers be they Medical Devices, IVD or bio/pharmaceuticals. 

The regulatory strategy for a bio/pharmaceutical or medical device product falls out of the above three areas and is largely dependent on: 

  1. The quality of information generated throughout the project
  2. How this information is presented

The right regulatory strategy is only arrived at if the information is clearly identified, understood and presented so an informed decision can be made. 

A regulatory filing is an information block which presents the normal challenges of big data, namely: 

  • Things we know that we know 
  • Things we know we do not know
  • Things we do not know that we know
  • Things we do not know that we do not know

A clear picture of a product is only arrived at by minimising the impact of the latter two statements on the information package prepared and presented for regulatory filing.  This is only possible if the information is presented in such a way that a true picture of the product can emerge from the information. Quite literally, “can you see the wood for the trees”?   

This is important because it means that any discussions with regulatory authorities can be conducted with greater confidence on all sides, making the review and approval process more efficient. 

Make the Regulatory Ethos work to your advantage: 

The recognition that the regulatory authorities are there to protect the public from harm has to be in the forefront of the mind of all regulatory professionals. 

The aim of Pirus Consulting is to use this ethos to the advantage of its clients by anticipating as many of the questions that the regulators may ask in advance of the filing and incorporating the appropriate information in the CTD, Technical File, PMA. or other large submission

This is a proven approach. Together with a well-structured dossier able to provide traceability from overall summary to detailed data, this can reduce review and approval time.