SEQ can help with the lifecycle management of an approved product portfolio, including providing the necessary support to meet any post-approval commitments, and during procedures to renew or vary a licence, or change the legal status of a product.
SEQ can help develop strategies for extending the life of a product through, for example, entering new markets or adding new indications.
SEQ services include (but not limited to) the following:
Development of strategies for post-approval variations to the marketing authorisation
Changes to manufacturing facilities or the process
Changes to product characteristics or presentation of the product
Extensions of shelf-life
Introduction of additional indications to the original marketing authorisation
Monitoring of post-approval commitments and responses to ongoing questions
Organisation of post-approval meetings with regulators to address future issues in product development
Discussion of variation strategies and timing with regulatory authorities
Compilation and submission of responses to ongoing commitments, and variation dossiers