MANUAL-REVIEW-ONLY • OFFICIAL SOURCES ONLY • NO AUTO-APPROVAL
Supplier Readiness Assessment — Pharma / APIs / Biosimilars / Veterinary Switzerland-focused readiness self-check for Indian exporters. This page separates TEPA tariff/origin readiness from Swissmedic authorisation, Swiss establishment licensing, SwissGMDP verification, BAZG customs handling, and buyer procurement onboarding.
Guardrail: Results are indicative only. This tool does not grant Swissmedic authorisation, establishment licensing, TEPA preference, customs treatment, buyer approval, or legal/regulatory advice. Every score requires document review by competent parties.
Universal 9-Dimension Scoring Governance
Current Swiss pharma readiness scoring snapshot
Origin Readiness is too low for routing or readiness progression. Readiness is currently RED because one or more critical dimensions are too low. Average indicative score: 44. Manual review is required before any routing or execution step.
This readiness page uses the shared platform scoring model: 9 dimensions, score bands of 0 / 25 / 50 / 75 / 100, indicative Green / Amber / Red output logic, and critical no-go checks for origin readiness, regulatory readiness, and evidence quality.
Product / Service Classification
Standard readiness dimension
Origin Readiness
Critical no-go dimension
Regulatory Readiness
Critical no-go dimension
Documentation Readiness
Standard readiness dimension
Market Access Readiness
Standard readiness dimension
Operational Readiness
Standard readiness dimension
Commercial Readiness
Standard readiness dimension
Counterparty Readiness
Standard readiness dimension
Evidence Quality
Critical no-go dimension
Universal score bands
0 ? No evidence 25 ? Basic claim only 50 ? Partial evidence 75 ? Substantial evidence 100 ? Complete evidence ready for manual review
Readiness scores are indicative only. They are not legal, customs, regulatory, tax, financial, origin, tariff, licence, provider, marketplace, or market-access advice. Official authorities, applicable law, customs decisions, regulator decisions, and manual platform review override any platform readiness indication.
1. Product Fit — Swiss pathway clarity Measures whether the exporter can identify the correct Swiss regulated pathway for API, finished medicine, biosimilar, or veterinary medicine. This is pathway readiness, not approval.
0 25 50 75 100
0 — Product route not identifiable
Cannot identify API, finished human medicine, biosimilar, or veterinary route. No awareness that Swiss medicinal-product distribution is regulated. 25 — Product route identified, Swiss pathway unclear
Product track is selected, but Swiss pathway references are missing. Swiss-side importer, authorisation holder, or licensing role is unclear. 50 — Basic Swiss pathway understood
Correct product track selected. Basic Swissmedic authorisation/licensing concept acknowledged. Swiss importer, MAH, or licensed-partner concept exists at high level. 75 — Swiss pathway mapped with minor gaps
Product mapped to relevant Swiss authority route. Regulatory pathway is kept separate from TEPA tariff/origin preference. Minor documentation or partner-role gaps remain. 100 — Track-specific pathway readiness pack prepared
Track-specific Swiss pathway pack is assembled for manual review. Correct official Swiss sources are referenced for the selected product track. Swiss-side licensed partner verification approach is documented where relevant. Manual-review note: Manual review required. This score does not imply Swissmedic authorisation, Swiss establishment licensing, TEPA preference, or buyer acceptance.
Official source pack 2. Certification Maturity — Swissmedic-relevant evidence Measures exporter and Swiss-side partner evidence: GMP/GDP legitimacy, SwissGMDP verification, foreign manufacturer evidence, and traceability/due diligence evidence.
0 25 50 75 100
0 — No Swiss-regulatory evidence
No Swissmedic-aligned GMP evidence pack. No traceability or due-diligence artefacts. No identified Swiss importer, wholesaler, MAH, or verifiable Swiss partner. 25 — Basic quality evidence only
General quality documents exist but are not packaged for Swissmedic foreign-manufacturer evidence review. Swiss partner may be named but SwissGMDP verification or role clarity is missing. 50 — One core Swiss pillar evidenced
Exporter has either GMP evidence or traceability evidence. Swiss partner is either verifiable in SwissGMDP or licensing role is clearly identified. 75 — Multiple Swiss pillars evidenced
Exporter has Swissmedic-aligned GMP evidence and traceability/due-diligence documentation. SwissGMDP verification is completed and Swiss partner role is mapped. 100 — Full track-specific evidence set
Exporter evidence pack includes GMP evidence, traceability pack, and submission-readiness awareness where applicable. Biosimilar track references official Swissmedic biosimilar sources. Veterinary track references Swissmedic veterinary framework and BLV/FSVO layer where relevant. Swiss partner verification and role clarity are documented for manual review. Manual-review note: Manual review required. Certification maturity is evidence-readiness only and does not confirm compliance or authorisation.
Official source pack 3. Export Track Record — regulated-supply maturity proxy Measures commercial maturity and prior controlled-supply-chain exposure. It is not a Swissmedic eligibility test.
0 25 50 75 100
0 — Domestic only
Sales entirely within India. No export history. 25 — Ad-hoc exporter
Occasional exports only. Limited structured documentation or quality-customer relationship evidence. 50 — Regular exporter
Regular exports to international markets. Some documentation discipline exists, but controlled-supply-chain evidence is incomplete. 75 — Regulated-market supply history
Supplier has experience with regulated or quality-demanding markets. Formal contracts or structured quality/customer requirements exist. 100 — Swiss/LI or EFTA/EU buyer history
Formal relationship with Swiss, Liechtenstein, EFTA, or EU buyer exists. Evidence remains subject to manual verification and does not imply regulatory clearance. Manual-review note: Manual review required. Export history does not replace Swissmedic authorisation, SwissGMDP verification, or TEPA origin review.
Official source pack 4. Traceability — batch/material traceability and recall readiness Measures batch, material, CoA, full-chain traceability, and recall-readiness evidence for controlled medicinal-product supply chains.
0 25 50 75 100
0 — No traceability
No batch records. No Certificate of Analysis capability. 25 — Basic records
Paper-based records only. Inconsistent batch identification. 50 — Batch-level CoA
Batch-level traceability exists. Certificate of Analysis is available per batch. 75 — Full chain traceability
Raw input to intermediate to finished goods linkage is documented. Material and batch movement evidence is available. 100 — Audit system ready
Digital traceability system exists. Recall procedure is documented and tested with evidence available. Manual-review note: Manual review required. Traceability maturity is not Swissmedic approval and does not replace Swiss-side licence checks.
Official source pack 5. ESG / Sustainability — buyer-driven due-diligence signal Measures sustainability and buyer due-diligence readiness. ESG is not Swissmedic authorisation and is not TEPA origin readiness.
0 25 50 75 100
0 — No ESG data
No sustainability reporting. No documented environmental compliance evidence available. 25 — Basic compliance
Environmental compliance evidence exists where applicable. No public sustainability reporting. 50 — ESG profile or reporting in progress
Supplier ESG profile or equivalent exists. Sustainability disclosure pack is in progress. 75 — Scored and climate data started
ESG assessment or equivalent buyer-ready evidence exists. Scope 1 and Scope 2 carbon data collection has started. 100 — Advanced ESG programme
Strong ESG assessment evidence or equivalent programme exists. Scope 1 and Scope 2 data available. Climate disclosure pack can support buyer reporting needs where relevant. Manual-review note: Manual review required. ESG score does not imply medicinal-product authorisation, customs preference, or buyer acceptance.
Official source pack 6. Documentation Quality — structured technical and quality documentation Measures whether the exporter can provide structured, reviewable technical and quality documentation for regulated medicinal-product supply chains.
0 25 50 75 100
0 — Minimal documentation
No technical documentation pack. No quality manual or SOP structure. 25 — Basic product specs
Simple product description only. Limited structured documentation. 50 — Technical documentation pack available
Technical pack exists. Quality manual draft or basic quality structure exists. 75 — Complete documentation
Technical pack, quality manual, test reports, and CoA capability available. Deviation or CAPA procedure documented. 100 — Buyer-ready data room
Complete technical and quality documentation package available in English. Version-controlled and updated within the last 12 months. Structured for buyer and manual regulatory-readiness review workflows. Manual-review note: Manual review required. Documentation quality does not imply Swissmedic acceptance or authorisation.
Official source pack 7. Buyer Ecosystem Fit — commercial channel maturity Measures commercial access and channel maturity. Buyer contact does not imply Swissmedic authorisation or product clearance.
0 25 50 75 100
0 — No contacts
No Swiss or Liechtenstein buyer/channel contact identified. 25 — Indirect contacts
Mission, directory, association, or indirect contact exists. 50 — Early-stage dialogue
Initial buyer, distributor, or Swiss-side partner conversation exists. 75 — Active relationship
RFQ, distributor negotiation, or Swiss-side onboarding discussion exists. Regulated-activity partner legitimacy still requires manual verification. 100 — Active supply chain
Purchase order, deliveries, active qualification process, or formal buyer relationship exists. Regulatory clearance and partner licence evidence still require manual review. Manual-review note: Manual review required. Buyer names, contacts, RFQs, or commercial discussions do not imply regulatory approval.
Official source pack 8. TEPA Origin Readiness — RoO and proof-of-origin only Measures whether exporter can prepare TEPA origin documentation for manual preference review. It does not assess Swissmedic market access.
0 25 50 75 100
0 — No RoO knowledge
No awareness of TEPA origin requirements. 25 — Aware of TEPA
Understands that TEPA preference requires origin qualification and proof. 50 — Initial RoO assessment done
HS code identified. Preliminary origin criterion or product-specific rule identified. Basic input-origin data exists. 75 — Origin evidence pack prepared
Bill of materials and input country-of-origin data available. Supplier declarations or supporting documents collected. Draft proof-of-origin path identified. 100 — Manual-review-ready origin file
HS classification, RoO/PSR assessment, origin evidence, and proof documents assembled. Ready for manual review only; no preference claim is auto-approved. Manual-review note: Manual review required. No TEPA preference, duty rate, or origin qualification is auto-approved.
Official source pack 9. Procurement Onboarding — RFQ, ERP and vendor qualification Measures operational and commercial readiness for buyer RFQs and vendor qualification. It is not a regulatory eligibility test.
0 25 50 75 100
0 — Not procurement-ready
No RFQ response capability. No buyer-ready documentation pack. 25 — Internal capability
Can respond to basic enquiry emails. Limited structured bid response capability. 50 — RFQ response capable
Can respond to formal RFQs with detailed technical bids in 5–10 business days. 75 — Systems-connected
ERP or structured procurement-response system exists. Can integrate with buyer procurement platforms or data exchange requirements. 100 — Vendor listing ready
Approved vendor list status exists with a target-market buyer, or active vendor onboarding is underway. Regulated-product clearance still requires separate competent-authority and partner-route review. Manual-review note: Manual review required. Procurement onboarding readiness does not imply Swissmedic authorisation or buyer acceptance.
Official source pack 