A Source of Quality and Regulatory Innovation
You are an established medium or large bio/pharma/medical or Medical devices company about to initiate regulatory filing for your new product
You have in-licenced products from other sources and are about to bring the filing up to standard or have modified manufacturing processes and need to include post approval/post-marketing variations.
By now there are hundreds if not thousands of reports on the various aspects of the Pre-clinical, CMC, development and manufacturing part of your product dossier (Technical Dossier or Common Technical Document).
Your decision on what to include to give an overall accurate picture of your product and avoid delays in the regulatory review process can speed up the return in your investment.
- For Medical Device companies, it is essential that the various aspects of the design, development, manufacture, evaluation and delivery meet the management and delivery criteria identified by ISO13485 and Medical Device or IVD directives and the recently finalised Medical Device and <IVD regulations> which pass these requirements from guidance into law.
- For bio/pharmaceuticals, where the size of the regulatory dossier is often larger, it is desirable and essential that the Pre-clinical/CMC part of the dossier forms a solid base and an integral part of your CTD. Pirus Consulting’s technical and Quality Management based approach is to work with your team to present the coherent concise account of the Pre-clinical/CMC part of the dossier mindful of the desired/intended labelling outcome. Pre-Clinical/CMC is not viewed in isolation, rather as an integrated base to the CTD triangle.
Pirus Consulting has the expertise to guide you to your regulatory goals efficiently.