← Analytical Development
Specifications, methods, and stability
The CMC sections of your dossier stay aligned with the analytical work behind them, in whatever format your target authority requires.
The filing was ready in March.
The dossier was ready in November
Regulatory Affairs is where the cost of the document-first paradigm lands hardest. The science finishes long before the paperwork does and every month between the two is a month of market share you will never recover.
- Domain owner
- Head of Regulatory Affairs · Submissions Manager · RA Operations
- Territories covered
- EMA · FDA · MHRA · PMDA · NMPA · ANVISA · TGA · Health Canada · 30+ more
- Submission formats
- eCTD v3.2.2 · eCTD v4.0 · NeeS · Regional variants
Capabilities
eCTD authoring and lifecycle management
Module 1 through Module 5, generated against the current eCTD specification for each authority: v3.2.2 where it remains in force, v4.0 where authorities have migrated. Sequence integrity and lifecycle continuity are preserved across the life of the product.
- eCTD v3.2.2 / v4.0
- NeeS
- Module 1 regional
- Module 3 quality
Variation and post-approval change management
Variations handled according to each territory's classification framework: EU Type IA / IB / II, FDA PAS / CBE-30 / CBE / Annual Reportable, and the equivalents in markets with their own regimes with the relationship between the change and its supporting evidence preserved across the lifecycle.
- EU Type IA / IB / II
- FDA PAS / CBE-30 / CBE
- Annual Reportable
- Worksharing
Filing strategy and territory planning
A current view of where each product stands across the territories you operate in. Filing strategy held as a property of the operation, rather than as a working document that ages between updates.
- Decentralised / MRP routing
- Reference product strategy
Agency interaction and correspondence
Your relationship with each authority: letters, meetings, deficiencies, responses: held as part of the operation rather than as an inbox. Decisions stay connected to the products and dossiers they belong to.
- Deficiency tracking
- Pre-submission meetings
- Scientific advice
Renewals, recertifications, and maintenance filings
The long tail of regulatory work: renewals, annual reports, and the regulatory portions of periodic safety updates: produced from current data, not from the state of the last filing.
- MA renewals
- Annual reports
- DMF / CEP renewals
Intelligence and regulatory horizon scanning
New guidance, evolving requirements, and format migrations are surfaced against the products they affect: turning regulatory change from a periodic review exercise into a continuous awareness.
- Guidance monitoring
- Format migration
- Portfolio risk view
Touchpoints
← Quality Management
Change control and CAPA evidence
When a deviation or change triggers a variation, the regulatory work and the quality event behind it remain connected, with their context intact.
← Clinical Bioequivalence
Bioequivalence study reports and statistics
Clinical sections reflect the underlying study work, so the dossier and the science it describes do not drift apart.
← Organizations & Resources
CDMO and supplier qualifications
Manufacturing site changes, supplier additions, and qualification statuses become part of the regulatory picture as they happen, not after.
← Labeling
SmPC, PIL, and labeling artifacts
Labelling stays in step with the global core safety information, localised per market without parallel maintenance.
← Pharmacovigilance
Safety updates and PSUR regulatory components
Safety signals that imply a regulatory action surface in the affected dossiers with the action already in view.
Outcomes
- −60%(indicative)
Time from ready dossier to first submission
The work of assembling and formatting filings is compressed; what your team spends time on shifts toward review and decision.
- −75%(indicative)
SME hours spent on variation authoring
The repetitive parts of variation work move out of SME hands. The judgment-heavy parts stay there, where they belong.
- +3×(indicative)
Territories filed in parallel
A single product team can sustain several times the parallel filing load without proportional headcount growth because the work is structurally different, not just faster.
Audit and inspection preparation time
Inspection readiness becomes a steady state rather than a project, because the records inspectors look for are already maintained as a matter of how the operation runs.
Figures marked indicative are directional benchmarks against comparable generics operations; per-customer numbers replace them in working sessions.
Want to talk?
Same foundation under every domain. A conversation usually clarifies where to start.