Life Cycle Managment

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

  • Gap analysis

  • Discussion of variation strategies and timing with regulatory authorities

  • Compilation and submission of responses to ongoing commitments, and variation dossiers

  • Renewals

  • Licence transfers

  • Reclassification of medicines

For more information please contact us at: enquiries@nerin.co.im