Marketing Authorisation Applications
Regulatory planning, dossier preparation and application support for human medicinal products.
Explore serviceOUR SERVICES
Regulatory Affairs Services
Specialist support for human medicinal products across the marketing authorisation and lifecycle continuum.
CTD/eCTD Dossier Preparation & Review
Consistent, reviewable regulatory dossiers and electronic submission support.
Explore serviceRegulatory Due Diligence
Structured regulatory risk assessment to support licensing, acquisitions and portfolio decisions.
Explore serviceVariations & Lifecycle Management
Regulatory control of post-authorisation changes over the product lifecycle.
Explore serviceRegulatory Gap Analysis
Identification of regulatory deficiencies and practical pathways to dossier readiness.
Explore serviceSmPC, PIL & Labelling
Regulatory preparation and review of medicinal product information.
Explore serviceRegulatory Strategy & Scientific Support
Pragmatic regulatory planning informed by technical evidence and market requirements.
Explore serviceMA Transfers, Renewals & Regulatory Maintenance
Support for ongoing responsibilities associated with authorised medicinal products.
Explore serviceHOW WE WORK
Defined scope and practical deliverables
Each engagement starts with an understanding of the product, planned procedure, available regulatory documentation and project objectives. We then agree the deliverables, review milestones and appropriate regulatory responsibilities.
Where relevant, support can encompass eCTD publishing, sequence preparation, technical validation and coordination of electronic submissions. Specific activities and access arrangements are determined for each engagement.
DISCUSS A PROJECT
Need specialist regulatory affairs support?
Get in touch to discuss the regulatory scope and documentation requirements for your project.