PHARMACEUTICAL REGULATORY AFFAIRS
Marketing Authorisation Applications (MAA)
Regulatory planning, dossier preparation and application support for human medicinal products.
SERVICE 01
Regulatory pathways and application planning
We support the identification and assessment of appropriate marketing authorisation routes in the United Kingdom and European Union, taking account of product characteristics, reference medicinal products, available data and procedural requirements.
Application documentation
Support may include the preparation, review and coordination of administrative, quality, non-clinical and clinical dossier content, with attention to consistency between modules and associated product information.
Procedure and authority questions
We support responses to regulatory questions, preparation of supplementary documentation and coordination of procedural milestones, working with the client and relevant technical experts.
Scope of support
Activities are defined for each engagement and may cover new marketing authorisation applications, abridged or generic applications, and other appropriate authorisation routes, as applicable.
Typical support activities
- Regulatory route assessment and submission planning
- Application documentation preparation and review
- Compilation and cross-checking of CTD/eCTD content
- Support during assessment and deficiency responses
- Coordination of regulatory application activities
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.