← Product Design
Methods anchored to the formulation
Each formulation carries its analytical methods as part of the same record: a formulation change surfaces the method work it implies.
The CMC anchor every dossier leans on
Analytical Development is the function that determines whether your CMC story holds together under inspection. The methods, the validation, the specifications, and the stability data are what every authority drills into first. Krevyos holds them as a connected, queryable, audit-ready dataset.
- Domain owner
- Head of Analytical · Method Development Lead · QC Operations
- Method scope
- Assay · Related substances · Dissolution · Particle size · Residual solvents · Microbiological
- Standards covered
- ICH Q2(R2) · ICH Q3A/Q3B · ICH Q6A · USP · Ph.Eur. · JP · regional
Capabilities
Method development and ICH Q2(R2) validation
Methods developed and validated against the current ICH Q2(R2) framework, with validation evidence connected to the methods it describes so a method change triggers the validation work it implies.
- Method development
- ICH Q2(R2)
Method validation and transfer
Validation parameters, results, and transfer protocols held as a single record per method so a method's history across labs is queryable rather than reconstructed.
- Method validation
- Method transfer
Specifications per ICH Q6A
Specifications structured per ICH Q6A, with the rationale, justification, and link to filing strategy attached so a tightening across territories is a propagation, not a parallel maintenance.
- Specifications
- ICH Q6A
Stability testing and shelf-life modeling
Stability protocols, time-course data, and shelf-life conclusions tied to the formulations, batches, and packaging configurations they describe across ICH Q1A long-term, intermediate, and accelerated conditions, so a shelf-life extension request to one territory carries the data that supports it without recomputing.
- Stability testing
- Shelf-life modeling
Impurity qualification per ICH Q3A/Q3B
Identified, unidentified, and degradation impurities tracked with qualification thresholds, structural elucidation, and the data that supports each so an authority question on impurity X has a queryable answer.
- Impurity qualification
- ICH Q3A / Q3B
Reference standards and working standards
Reference and working standards held with their characterization data, transfer protocols, and chain-of-custody evidence: ready for inspection, not assembled for it.
- Reference standards
- Working standards
Touchpoints
→ Regulatory Affairs
Module 3 sections, generated from the work
Module 3 quality sections are generated from the analytical record: never out of sync with the methods, specifications, and stability data they describe.
→ Quality Management
OOS investigations and method linkage
Out-of-specification results carry the method, the batch, and the investigation as a connected record so root cause analysis has the analytical context it needs.
↔ Organizations & Resources
Contract lab oversight
Methods executed at contract labs share the same method record as in-house work so transfer, validation, and routine execution don't fork into parallel datasets.
Outcomes
- −65%(indicative)
Time spent on Module 3 quality authoring
The narrative is generated from the analytical record rather than reconstructed from spreadsheets and lab notebooks.
Method drift undetected between labs
Method records are shared across labs by design; divergence between in-house and contract execution surfaces as a property of the data.
- +4×(indicative)
OOS investigations closed within target cycle time
Investigations start with the method, batch, and historical context already assembled: analyst time goes to interpretation.
- 100%(indicative)
Specifications traceable to their justification
Every specification limit carries the data and rationale that justified it: auditable on demand, queryable for the next product.
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.