1Marketing application compilation and submission
NDA, BLA and 505(b)(2) applications in electronic common technical document format
The position today
Compilation runs an assessed six to twelve months10. Cross-module consistency errors are common because each module is assembled separately. Regulatory milestone dates are tracked informally, often in a spreadsheet held by one person.
What MedicOrbis does
Automated compilation with cross-reference integrity checked as the package is built, milestone date tracking against the record, and management of Breakthrough, Fast Track, Accelerated Approval and Priority Review designations, including the biosimilar pathway.
Between 2008 and 2017 the FDA issued refuse-to-file letters on 4.0 per cent of new drug applications and efficacy supplements it received. Of the 644 reasons cited across those letters, 15.5 per cent were about how the application had been organised, formatted or assembled, not the science2.
Risk of leaving it manual: A refuse-to-file letter can push a launch back by many months2, and a single day of delay is worth about $800,000 in lost prescription sales1.
Runs on: marketing application submission, submission assembly and filing, and investigational application lifecycle management.
2Post-market pharmacovigilance
Individual case safety reports, signal detection and periodic safety reporting
The position today
Safety operations run on legacy systems. Signal detection is retrospective. Periodic reports take an assessed three to six months to author10. Electronic transmission standards are met inconsistently.
What MedicOrbis does
Full case lifecycle management with automated submission to multiple agencies from one entry, literature monitoring, periodic report authoring from the underlying cases, and a signal management workflow with benefit-risk assessment.
In March 2026 the FDA issued a warning letter to Novo Nordisk following an inspection of its safety operations. The agency cited failures to meet postmarketing adverse experience reporting requirements, including reports not submitted within the required 15-day window4. The FDA was explicit that this concerned how quickly safety information reached the agency, not whether the medicines caused the events.
Risk of leaving it manual: Missed safety signals cause patient harm, and recalls and litigation on the scale of billions of dollars8.
Runs on: periodic safety report generation, expedited serious event reporting, and adverse event capture and assessment.
3Multi-jurisdictional regulatory intelligence
Knowing what changed, in every market, before it affects a live submission
The position today
Intelligence is gathered by hand from government websites. The impact of a change on active programmes is worked out after the fact. There is no cross-jurisdictional view from which to optimise strategy.
What MedicOrbis does
Monitoring of regulatory change across more than ten jurisdictions10, automated impact assessment against live submissions and marketed products, a guideline comparison engine, and cross-jurisdictional submission strategy.
A peer-reviewed analysis of 664 medical device regulations and guidelines issued across the United States, the European Union and China over the past decade found the volume of regulatory documents rising in all three jurisdictions6.
Risk of leaving it manual: The volume of regulatory change is rising in every market6, and a change missed in any one of them means non-compliance.
Runs on: regulatory intelligence monitoring with impact assessment, and health authority information request response.
4Clinical evaluation for European device regulation
Clinical evaluation plans and reports, and post-market clinical follow-up
The position today
Authoring takes an assessed six to twelve months per device10. Literature searches are not reproducible. Equivalence justification is contentious. Post-market follow-up is rarely connected back to the evaluation it should inform.
What MedicOrbis does
Structured authoring against a defined evidence hierarchy, automated literature search with systematic-review tracking, a state-of-the-art library, gap analysis against safety and performance requirements, and a live link from evaluation to post-market follow-up.
In MedTech Europe's industry survey, 50 per cent of respondents said their clinical evaluation had been significantly challenged by their notified body on at least one application, and respondents identified the absence of a clear definition of sufficient clinical evidence as an obstacle for legacy devices5.
Risk of leaving it manual: Clinical evaluation is the most frequently challenged part of a submission: half of manufacturers surveyed had one challenged by their notified body5.
Runs on: clinical evaluation report authoring and maintenance, and post-market clinical follow-up management.
5Technical documentation and requirements compliance
Technical files, the safety and performance requirements matrix, labelling and device identifiers
The position today
Technical documentation is scattered across systems. Traceability from each requirement to its evidence is maintained by hand. Multilingual labelling translation is managed chaotically.
What MedicOrbis does
Structured technical file templates, a requirements compliance matrix with a linked evidence library, verification and validation evidence management, multilingual labelling and instructions-for-use control, and device identifier assignment with registry submission.
MedTech Europe reports that re-certifying a single technical documentation certificate after five years costs on average about 94 per cent more than the initial certification, at roughly EUR 342,000 for a medical device, and that manufacturers face around a 50 per cent rise in maintenance and re-certification spend across a five-year cycle5.
Risk of leaving it manual: The file is re-audited, re-priced and re-argued every cycle, and the second time costs more than the first5.
Runs on: the device conformity marking submission process.
6Statistical analysis and submission datasets
Analysis plans, submission-ready datasets, tables, listings and figures
The position today
Generating submission datasets is among the most time-consuming work in biostatistics and is largely manual. Table and figure production is manual too. Interim analyses require complex unblinding procedures handled outside the system.
What MedicOrbis does
Automated submission dataset generation with a full audit trail, automated production of tables, listings and figures, interim analysis with alpha spending, safety monitoring board package generation, and Bayesian and causal inference engines.
Since September 2021 the FDA has applied Technical Rejection Criteria for study data at its Electronic Submissions Gateway. A submission whose datasets do not conform to the required standards is rejected automatically, before any reviewer reads a word of it3.
Risk of leaving it manual: Non-conformant data is no longer a review comment. It is an automated rejection at the gateway3.
Runs on: central statistical monitoring, database lock and unblinding, and clinical study report generation.
7Device vigilance and field safety action
Serious incident reporting and field safety corrective actions
The position today
Incident reporting deadlines are tracked manually against differing jurisdictional clocks. Field safety actions are coordinated over email, with no single view of which customers have been reached or acknowledged.
What MedicOrbis does
Incident capture with automatic determination of reportability and deadline by jurisdiction, coordinated field safety action execution with distribution and acknowledgement tracking, and effectiveness verification recorded against the action.
Philips Respironics recalled millions of sleep and respiratory devices from June 2021. In January 2024 the company agreed a consent decree with the US Department of Justice and the FDA, entered by the court that April7. Separately, in April 2024 Philips agreed to pay USD 1.1 billion to resolve US personal injury litigation and a medical monitoring class action8.
Risk of leaving it manual: A field safety action handled poorly can escalate to a consent decree7 and to litigation on the scale of billions of dollars8.
Runs on: device vigilance and serious incident reporting, and field safety corrective action execution.