The operating system for the generics portfolio
From business planning to lifecycle management and pharmacovigilance: connected data, governed workflows, and documented decisions in one environment.
- ~85%
The average price erosion within two years of the first generic launch in a given market. Speed is everything.
- 12–18mo
The typical lag between a scientifically ready dossier and the actual filings going out across major territories. This delay is almost entirely driven by internal assembly and formatting.
- 40+
The number of territories a single generic product is commonly filed into, with each region demanding its own variation requirements and renewal cycles.
— 01
Immediate impact awareness
Krevyos holds each product as one connected record. Change an API source, a specification, or a manufacturing site, and the platform surfaces every place the change touches: which dossier, in which territory, which labels. What used to be dozens of parallel updates reconciled by hand becomes one controlled action.
— 02
Constant audit-readiness
Every data point in Krevyos carries its provenance, its approver, and its regulatory linkage from the moment it is recorded. The audit trail is a standing property of the system. When a regulator asks for records, remotely or on site, the evidence is already complete, attributable, and current.
— 03
Filings derive from the data
Applications, variations, and renewals are generated from approved data elements on demand. Your team stops rebuilding documents for every market because filings become an output of the registered and approved information living in the platform.
Thirteen services. One coherent system
Krevyos Generics is organized around the thirteen services that define how a generics company actually operates from the first business case for a molecule to its post-launch surveillance.
01: Strategy
Business Planning
The strategic decisions that shape what your portfolio is and where it goes.
02: Formulation
Product Design
The development that turns a target product into something manufacturable.
03: Materials
Materials & Substances
APIs, excipients, and raw materials: held as living substance masters.
04: Methods
Analytical Development
The methods, validations, specifications, and stabilities that anchor your CMC story.
05: GxP
Quality Management
CAPAs, deviations, and change controls: the quality core of a regulated operation.
06: Organizations
Organizations & Resources
CDMOs, API suppliers, service providers, and lab partners: linked directly to your operation.
07: Clinical
Clinical Bioequivalence
BA/BE results and supporting evidence.
08: Submissions
Regulatory Affairs
Filings, variations, renewals, and agency correspondence across every territory you operate in.
09: Surveillance
Pharmacovigilance
The full post-marketing safety lifecycle.
10: Medical
Medical Affairs
Medical information, scientific content, and their reviews.
11: Labeling
Labeling
Labels handled as structured information, so territory formats derive from it.
12: Identity
Product Codification
The identifiers that let your product exist in the world's supply chains, reimbursement systems, and regulatory ledgers.
13: Commercial
Market Access
The commercial work that turns a regulatory approval into a launched, reimbursed, accessible product.
+ Architecture
One shared foundation
The thirteen services operate on a common foundation rather than as separate systems. Changes propagate where they need to. Provenance is preserved. The platform handles the connective work that operations teams typically maintain by hand.
Pick a domain to go deep
Each of the thirteen services has its own page: what it owns, what it connects to, what it changes for the people who do the work today.