Manufacturer qualification
Inspection history, audit reports and technical capability are reviewed before any product is considered.
Standards
Documented
from start to shelf.
European good manufacturing practice, verified analytics and full traceability form the backbone of every VARENQOR PHARMA product.
Analytical verification
Specifications, stability data and method validation are assessed independently of the manufacturer's claims.
Regulatory dossiers
eCTD documentation maintained for European and international registration pathways.
Serialisation
Unique identifiers and tamper-evident packaging in line with falsified medicines requirements.
Good distribution practice
Temperature-controlled, monitored storage and transport with documented handover points.
Pharmacovigilance
Safety reporting and signal management obligations carried for every branded product.
Commitments
No exceptions,
no shortcuts.
01
Batch traceability
Every unit can be traced back to its release documentation and manufacturing batch.
02
Change control
Any change at a partner site is assessed before it reaches a VARENQOR-branded product.
03
Supplier audits
Periodic re-audits confirm that qualification is maintained, not assumed.
04
Complaint handling
Defined timelines for technical complaints, recalls and safety escalations.
Documentation
Request quality
documentation.
Registered partners can request dossier summaries, CoAs and GMP certificates for evaluation.
Request documents