Our Regulatory Submissions A-Team encompasses publishing and submissions, medical writing, and regulatory affairs experts to ensure comprehensive management and preparation of all necessary documentation to meet or exceed regulatory standards.
Our integrated approach streamlines the approval process and ensures consistent, high-quality submissions. With cross-functional expertise, including professionals with regulatory authority experience, we can ensure the information is presented most effectively to regulatory bodies.
Publishing and Submissions
Our expert team delivers comprehensive eCTD publishing services and expertly manages the entire submission process to meet regulatory requirements for global authorities such as the US FDA, Health Canada, EMA (EU), and MHRA (UK).
Benefits of Our Streamlined Approach
We streamline document preparation, submission building, and lifecycle management using advanced tools and software, ensuring efficient and compliant submissions.
Our solutions minimize errors and accelerate timelines, allowing your team to focus on core activities while maintaining regulatory standards.
Publishing and Submissions Services
- LORENZ docuBridge software
- Full eCTD publishing services
- US FDA, Health Canada, MAA, EU
- Document remediation and compilation
- Submission build
- Application lifecycle management and archive
- CSR publishing
- Submission of Facility and Product Registrations
- Application SPL coordination and management
- Publishing via the Electronic Submissions Gateway (ESG) and per Regulatory Authority requirements
Regulatory Submissions and Experience
With over
13
former regulators
From
6
regulatory agencies
And
825+
annual regulatory submissions
Plus, a track record of
61
successful marketing applications
“Successful regulatory submissions require a strategic approach and meticulous management. By focusing on aligning each submission with regulatory expectations and streamlining the process, we ensure that small to mid-sized biotechs can advance their innovations effectively and efficiently.”
Nadine Bouchard
VP, Regulatory Affairs & Program Management
