PHARMACEUTICAL REGULATORY AFFAIRS
MA Transfers, Renewals & Regulatory Maintenance
Support for ongoing responsibilities associated with authorised medicinal products.
SERVICE 08
Marketing authorisation transfers
We provide regulatory coordination and documentation support for marketing authorisation transfers, including assessment of applicable country-specific requirements and alignment of the relevant records.
Renewals and continued validity
We support the planning, compilation and review of documents needed for renewal procedures and continued authorisation maintenance, where applicable.
Regulatory maintenance
Support may include tracking product authorisation particulars, post-authorisation commitments, submission documentation and consistency of product information across relevant markets.
Typical support activities
- Marketing authorisation transfer documentation
- Renewal procedure planning and documentation review
- Authorisation status and maintenance assessment
- Lifecycle submissions and follow-up
- Coordination of approved product information and regulatory records
Services and deliverables are subject to a project-specific scope of work and the relevant regulatory framework.
DISCUSS A PROJECT
Need specialist regulatory affairs support?
Get in touch to discuss the regulatory scope and documentation requirements for your project.