Agos Pharma provide regulatory support for all stages of product lifecycle management for your approved product. Updates to the product dossier may be required to maintain compliance with current guidelines and to implement changes to the manufacturing process.
Variations
We can help manage changes to your product dossier by providing an optimised variation submission strategy, including, authoring, eCTD publishing and submission of the appropriate variation.
Post authorisation studies
After product approval you may be required to complete certain activities which may include further clinical studies or updates to the manufacturing process. These activities can be categorised as Post Authorisation Measures (PAMs), Post Authorisation Efficacy Studies (PAES) and Post Authorisation Safety Studies (PASS). The Agos Pharma regulatory team will liaise with our Clinical Development group to design the optimum strategy for post authorisation clinical/efficacy studies. We can guide you through the entire process from designing the studies, liaising with regulatory agencies and submission of the final study reports.
Risk Management Plans
An update of the RMP may need to be submitted at any time during a product’s lifecycle. Agos Pharma can help with all procedural and regulatory aspects relating to life cycle maintenance of the RMP.
Periodic Safety Update Reports
A PSUR is an important pharmacovigilance document which provides an evaluation of the risk-benefit balance of a medicinal product at defined time points post-authorisation. We can help author, review and submit your PSUR and advise on strategy to harmonise PSUR cycles.
Agos Pharma can also provide assistance with other post approval activities such as, Renewals, Transfer of Ownership, Marketing and Cessation Notifications and Sunset Clause Monitoring.
