Accelerated submission: from database lock to submission-ready in record time

The submission bottleneck

In the final stages of drug development, the gap between database lock and submission filing is often the critical path. Manual data cleaning, sequential modelling, inconsistent ways of working, and limited regulatory experience can introduce delays that cost months of market exclusivity.

For many sponsors, this bottleneck is not a resourcing problem. It is a structural one.

Engineered for speed, guided by expertise

We do not just work harder. We work differently.

Our accelerated submission framework is built on standardization, parallelization, and reproducibility. Experienced project leaders establish detailed, realistic plans from the outset, and every consultant operates from the same validated workflows, templates, and script packages.

With a critical mass of 60+ Ph.D.-level consultants, we front-load tasks and execute in parallel. This scale is only effective because of the rigorous consistency across our teams.

Every project is steered by experienced project leaders and senior advisors who bring collective intelligence to complex regulatory challenges.

Our automated reporting system then ensures a rapid, error-free path from database lock to a final, submission-ready report on reproducible research principles; we can regenerate full, submission-ready reports within days of receiving the final database lock.

We partner with your clinical pharmacology and pharmacometrics teams to de-risk and accelerate NDA, BLA, and MAA submissions across the full submission pathway

• Regulatory defense: proactive identification of potential agency concerns, with robust, evidence-based responses drafted and ready before queries arise.
• Early strategic mapping: a comprehensive MIDD roadmap established well before Phase III initiation, so your team enters the critical path with a clear plan.
• Integrated modelling: rigorous PK and PK/PD analyses covering both clinical efficacy and safety endpoints.
• Evidence-based dosing rationale: fit-for-purpose methodologies, including Full Random Effect Methods (FREM), used to derive actionable dosing recommendations and justify labelling across diverse patient populations.
• Traceable documentation: submission-ready reports generated through our proprietary reproducible reporting system, with every table, figure, and listing linked directly to the source data.
• Dossier authoring: expert authorship and alignment for CTD Modules 2 and 5, ensuring consistency across your full submission package.

1. Reproducible research & reporting

In most organizations, reporting is a manual step performed after analysis is complete. We treat reporting as code.

• Fact: a proprietary, script-based reporting system where every table, figure, and listing is directly linked to the source data.
• Benefit: total traceability across your submission package, with the ability to update all outputs instantly if the data changes.

2. Large-scale & effective parallelization

More people only help if everyone is working from the same playbook.

• Fact: 60+ dedicated MIDD consultants, one of the largest specialised pools in the industry.

• Benefit: we assign a tailored team where every consultant works from the same validated templates and scripts. Multiple workstreams run in parallel, with consistent, harmonized deliverables from start to finish.

3. Dedicated data programming & independent QC

Quality is built into the process, not checked at the end.

• Fact: every project is supported by an efficient data programming team and a separate, independent QC team.

• Benefit: analysts focus on the science while the data team ensures CDISC compliance, and an independent QC team provides a second-gate check. The result is fewer back-and-forth errors and faster, cleaner submissions. 

4. A proven track record of success

Claims of expertise are easy to make. Consistent, documented results are not.

• Fact: 100+ successful regulatory submissions since 2012, including one to two NDA, BLA, or MAA filings every quarter on accelerated timelines.

• Benefit: deep familiarity with FDA, EMA, and PMDA expectations. Our templates are aligned with current ICH M15 guidance and have been validated through real submissions in front of global regulators.

Affiliated publications and abstracts

• Jonsson EN et al. Conditional versus unconditional covariate effects in pharmacometric models: implications for interpretation, communication, and reporting CPT:PSP. 2026.
• Jonsson EN and Nyberg J. Full random effects models (FREM): A practical usage guide CPT:PSP. 2024;13:1297–1308.
• Jonsson NE and Nyberg J. Using forest plots to interpret covariate effects in pharmacometric models CPT: PSP. 2024;13:743–758.
• Moroso V et al. Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics Medical writing. 2023;32:56-63.
• Magnusson MO and Jonsson EN. Reproducible reporting. PAGE 25 (2016) Abstr 6075.
• Glatard A et al. Expediting MIDD evidence generation to support quizartinib approval in newly diagnosed AML patients PAGE 33 (2025) Abstr 11445.
• Buatois S et al. Pharmacokinetic Characterization and Exposure-Response Relationship of Crovalimab in the COMPOSER and COMMODORE 3 Trials of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Blood (2022) 140 (Supplement 1): 2918–2920.
• Schmid U et al. Exposure-safety analyses of nintedanib in patients with chronic fibrosing interstitial lung disease BMC Pulm Med. 2021 Jul 21;21(1):244.
• Schmid U et al. Exposure-efficacy analyses of nintedanib in patients with chronic fibrosing interstitial lung disease Respir Med. 2021 Apr-May:180:106369.
• van Beek S et al. Population pharmacokinetic analysis of elafibranor and metabolite GFT1007 to support exposure-response characterization and dose selection in patients with primary biliary cholangitis PAGE 32 (2024) Abstr 11117.
• Aguiar Zdovc J et al. Population pharmacokinetic-pharmacodynamic analysis of elafibranor and metabolite GFT1007 to support exposure-response characterization and dose selection in patients with primary biliary cholangitis PAGE 32 (2024) Abstr 11090.
• Kassir N et al. Exposure-Response Analysis of Etrolizumab in Patients with Moderately-to-severely Active Ulcerative Colitis ACoP12 (Nov 2021) PMX-82.

Our commitment to advancing the field of pharmacometrics is demonstrated through our active participation in scientific research and publication. This work not only contributes to the broader scientific community but also ensures our partners benefit from the most current and validated methodologies.

Whether you are in early-stage strategic planning or preparing for regulatory submission, our experts are ready to discuss how our accelerated submission services can optimize your program. 

Ready to accelerate your submission strategy?

• Engage us for expert advice on strategic, regulatory, or technical matters at any stage of your study or program.
• Contract with us for milestone projects to perform specific analyses, such as a complete model-based bioequivalence analysis.
• Hire an embedded scientist to work as part of your team, either full- or part-time, giving you hands-on support guided by our senior consultants.
• Empower your in-house team with customized training workshops tailored to their specific background and needs.