Management of Regulatory Procedures and dossier preparation
Assion services are:
- Support for the preparation of registration dossiers in eCTD format including critical sections (e.g. Pharmacovigilance System Master File, Risk Management Plan, Environmental Risk Assessment)
- Advise on different local requirements for the submission of applications
- Management of the regulatory procedures (EU, US and worldwide)
- Assistance in preparing and attending oral hearings with the authority before and during procedures
- Assistance in writing response documents to authority deficiency letters/list of questions
- Assistance in updating dossier sections in response to authority deficiency letters during the registration procedures
On demand regulatory team an Assion case study
A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.