Paving the way to streamlined regulatory submissions
Accelagen is a trusted partner for the biotech and pharmaceutical industries, navigating the complexities of the regulatory submission process with ease to achieve the best outcomes.
Our expertise is global and proven across all forms of applications. We prepare andpublish submissions for regulatory agencies across the Asia-Pacific, Europe and North America. Our applications consistently reflect newindustry shifts and modern best practice, as well as complying with regulatory standards and technical requirements.
- Preparation of eCTD dossiers using Lorenz DocuBridge system
- Tracking of eCTD lifecycle during product lifespan to maintain up-to-date regulatory files
- Secure Document Management System systems
- Validation of published submissions in accordance with local and international Regulatory Agency specifications
- Different submission types, including IND, BLA, NDA, IDE, MAA and Category 1/3 submissions
How we work
Proven expertise delivers application succes
Accelagen’s deep understanding of regulatory landscapes is demonstrated in hundreds of successful applications, including New Drug and Biological Applications to the FDA, Category 1 submissions in Australia, generic/biosimilars, as well as Investigational New Drug (IND) submissions, orphan drug designations and pre-market approvals.
Combining technical prowess and regulatory knowledge
Accelagen provides a full eCTD submission publishing service underpinned by high quality software, alignment with current regulatory standards and rigorous quality control to ensure a streamlined submission process to International Regulatory Agencies.
Submission publishing and management
case studies
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