→ Materials & Substances
The supplier behind every material
Each API, excipient, and raw material links to the qualified organization that supplies it, so a supplier change or disqualification reaches every material and product that depends on it.
Your partners and sites are part of the operation
Suppliers, manufacturing sites, contract labs, and your own legal entities each carry the qualifications, certificates, licenses, and agreements that decide whether a product can be sourced, made, tested, or filed. Most operations keep them as folders of documents that age the day they are filed. Krevyos holds them as live records, so a lapsed GMP certificate, an expiring agreement, or a disqualified supplier shows up before it stops a filing, not after.
- Domain owner
- Supplier Quality · Supply Chain · Regulatory Affairs
- Covers
- API & excipient suppliers · CMOs / CROs · Contract labs · Manufacturing sites · Distributors · Named responsibles
- Standards
- GMP · GCP · GDP · ICH Q7 · PIC/S · WHO TRS 961
Capabilities
Supplier and site qualification
Suppliers, CMOs, and contract labs are qualified against the framework each one operates under, whether GMP, GCP, or GDP, with the audit outcome and the site's current status held as a standing record. A supplier that falls out of qualification is visible everywhere it is used, not just in the auditor's inbox.
- GMP / GCP / GDP
- ICH Q7
- PIC/S
Certificates and licenses, kept current
GMP certificates, manufacturing and testing licenses, wholesale distribution authorizations, and import permits are tracked with their validity, so an expiry surfaces as a renewal reminder and a filing flag well before it lapses, not during an inspection.
- GMP certificates
- WDA / import licenses
- Expiry tracking
Quality and technical agreements
Quality agreements, supply contracts, and distribution agreements are held alongside the partners and products they govern, with the obligations they encode and their in-force dates tracked, so a lapsed or superseded agreement never goes unnoticed.
- Quality agreements
- FDA Quality Agreements guidance
- Renewal tracking
Technology transfer to partners
When production or testing moves to a new site, the transfer runs against that site's qualification, so its milestones and the site that inherits the work stay connected rather than living in a separate project plan.
- WHO TRS 961 (Annex 7)
- ICH Q10
- Transfer milestones
Authority registrations and named responsibles
Your own legal entities carry their regulator registrations, from ANMAT to FDA to ANVISA, and the individuals accountable for them: the QP, the RP, the QPPV, the Director Técnico, as part of the same record the filings draw on.
- ANMAT · FDA · ANVISA
- QP · RP · QPPV
- Establishment registration
Touchpoints
→ Regulatory Affairs
Manufacturing site changes and variations
Site changes, supplier additions, and qualification statuses become part of the regulatory picture as they happen, not after a quarterly review.
↔ Quality Management
Partner audit findings and quality agreements
Audit findings and quality agreement obligations live alongside the partners they govern: change controls at a partner site flow into the operation as they happen.
↔ Analytical Development
Contract lab method execution
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.
→ Product Design
Tech transfer to CDMOs
When development work transfers to a CDMO, the partner inherits the live process record rather than a static PDF that ages from the moment it's sent.
→ Pharmacovigilance
The QPPV as a named responsible
The individual accountable for pharmacovigilance is held as a named responsible of your organization, so the person on the safety filings is the person of record, current and attributable.
Outcomes
- −55%(indicative)
Time from partner shortlist to qualified
Qualification reuses prior audit work where the supplier has been qualified for another product: without reconstructing it.
Partner-related findings reaching post-approval
Capability gaps surface during qualification rather than during a deviation post-launch.
- 100%(indicative)
Certificates and licenses tracked to expiry
Every GMP certificate, license, and authorization carries its validity, so a lapse is a renewal reminder ahead of time rather than a finding after the fact.
- +2×(indicative)
New products onboarded to an existing partner
An onboarding to a partner you already use starts from their existing capability profile: speed-to-supply rises without a proportional rise in qualification work.
Figures marked indicative are directional benchmarks against comparable generics operations; per-customer numbers replace them in working sessions.
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