1. Development phase support
We provide regulatory support from the early stages of your project. Our regulatory experts are actively involved in project teams and assist with:
- Regulatory strategy and CMC guidance
Development of regulatory plans in line with applicable chemistry, manufacturing, and controls (CMC) requirements and project goals. - Pre-submission activities
Support with planning and preparation of regulatory authority interactions during early development phases. - Dossier preparation (modules 2.3 and 3)
Compilation and authoring of documentation in accordance with current standards for regulatory submissions.
2. Regulatory submission – new marketing authorisation applications
We support the full process of submitting new marketing authorisation applications and ensure regulatory compliance throughout all steps.
- Team participation
Active involvement in internal project teams to enable efficient coordination. - Procedure management
Representation during meetings with regulatory authorities and support with handling authority requests and responses. - Dossier compilation (modules 1, 2.3 & 3)
Preparation and adaptation of technical documentation, including scientific justifications and response documents. - Electronic submission (EU)
Full support for eCTD submission. - Post-authorization activities
Management of changes following approval, including authorisation transfers, name changes, and regulatory follow-ups.
3. Lifecycle management – post-approval submissions
We provide regulatory support throughout the entire lifecycle of your product, ensuring continued compliance after initial approval:
- Ongoing regulatory project support
Continuous involvement in project teams during lifecycle management activities. - Lifecycle procedure management
Handling of variations and renewals, including communication with authorities and preparation of responses to regulatory requests. - Dossier updates (module 3)
Preparation and submission of updated documentation in line with current global regulatory requirements. - Electronic submissions (EU)
Lifecycle-related submissions in eCTD format, in accordance with applicable guidelines.
With experience managing thousands of active marketing authorisations worldwide, we offer a reliable foundation to support your post-approval regulatory needs.
