Accelerated submission

Challenge

Solution

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.

Services

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.

Benefits

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.

Challenge

Solution

Services

Benefits

Case studies & success stories

Publications and abstracts

Supporting resources

Our collaboration solutions

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