← Regulatory Affairs
Approval as the launch trigger
A regulatory approval surfaces the market access work it implies: HTA filings, reimbursement applications, country launches with the dependencies and timing already visible.
An approval is not a launch
Market Access is where a generic stops being a regulatory artifact and starts being a product patients can actually get. It's also where most operations discover that the data they needed to argue for reimbursement is scattered across PDFs filed for a different audience. Krevyos puts that data where market access can use it.
- Domain owner
- Head of Market Access · HTA Lead · Pricing Strategy · Launch Manager
- HTA bodies
- NICE · G-BA · HAS · AIFA · CADTH · PBAC · ANVISA CMED · plus more
- Commercial scope
- HTA submissions · Pricing & reimbursement · Tender management · Launch readiness · RWE
Capabilities
HTA submissions per country framework
Health Technology Assessment submissions for the major HTA bodies (NICE, G-BA, HAS, AIFA, CADTH, PBAC) generated from the same data the regulatory submission was built from, with the cost-effectiveness framing each body requires, so an evidence gap surfaces before the submission goes in rather than as a clarification request after.
- HTA submissions
- ICER frameworks
Pricing strategy and reference price tracking
Reference pricing across territories tracked as a live property: competitor entries, price erosion, and reference-price implications visible against the portfolio they affect.
- Pricing strategy
- Reference price tracking
Reimbursement tracking and tender management
Reimbursement status per country, payer, and tender: held as a live record across the launch lifecycle, with the regulatory milestones and labelling that each step depends on already linked.
- Reimbursement tracking
- Tender management
Launch readiness per country
Country-by-country launch readiness: regulatory approval, reimbursement listing, supply chain readiness, and labelling: held as a single readiness view, not a launch-team spreadsheet.
- Launch readiness
- Country-by-country planning
Real-world evidence and benefit-risk
Real-world evidence captured from post-marketing safety, utilization data, and outcomes research: feeding HTA refreshes, benefit-risk updates, and tender renewals from the same dataset.
- Real-world evidence
- Benefit-risk dossiers
Touchpoints
← Pharmacovigilance
Benefit-risk and RWE for HTA
Benefit-risk assessments and post-marketing safety information feed the commercial and HTA work without being rebuilt for it from scratch.
← Product Codification
Reimbursement codes and payer identifiers
Reimbursement identifiers and payer codes flow from the master record into market access work so tender submissions and payer applications inherit the structural data.
← Labeling
Indications and label-driven access
Country-specific indication wording and label extensions feed market access positioning: without parallel maintenance.
← Business Planning
Portfolio strategy and territory prioritization
Market access feedback: reimbursement outcomes, HTA decisions, competitor entries: feeds back into business planning as live signal, not as a quarterly retrospective.
Outcomes
- −40%(indicative)
Time from approval to first reimbursement
HTA and reimbursement work starts from the same data the regulatory submission was built from: assembly replaces re-derivation.
- +2×(indicative)
HTA submissions per market access team per cycle
The team's bandwidth scales with the operation rather than with the cost of finding the data each submission needs.
- 100%(indicative)
Country launches tracked against the same readiness model
Every country launch is visible in the same readiness frame: regulatory, reimbursement, supply, labelling with dependencies traceable.
HTA submissions delayed by data hunts
The data HTA bodies expect is already in the operation. Submission time becomes synthesis, not search.
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 service. A conversation usually clarifies where to start.