Compliance-Assured RLD & Comparator Sourcing Oversight

Regulatory-assured sourcing of reference listed drugs (RLDs) and comparator products for ANDA, MAA, biosimilar, and complex generic development programs — delivered with full GDP compliance oversight and audit-ready documentation.

Axentra Global Pharma Compliance provides end-to-end coordination of comparator drug sourcing while serving as your independent GDP compliance and regulatory assurance partner. Our approach focuses not only on securing supply, but on ensuring every comparator shipment stands up to regulatory scrutiny during audits and inspections.

Global regulators increasingly examine comparator sourcing documentation during ANDA, MAA, and biosimilar submissions. Missing temperature records, unclear chain-of-custody, unqualified wholesalers, or incomplete traceability frequently become avoidable inspection observations and filing deficiencies. Axentra exists to eliminate this risk.

Comparator Sourcing Coordination

Axentra provides full operational coordination of comparator procurement across global markets:

Identification and qualification of licensed wholesalers and legal supply sources
Verification of reference standard matching (strength, dosage form, route of administration, label identity, market of origin)
Cross-border availability assessments where local sourcing is restricted or limited
Sponsor ↔ wholesaler procurement coordination
Import/export documentation support
Shipping route planning using GDP-certified cold-chain couriers
Delivery scheduling aligned to bioavailability studies, stability programs, and dossier timelines

Our coordination ensures that comparator material sourcing is practical, compliant, and aligned with development schedules — without exposing sponsors to unverified traders or documentation gaps.

Regulatory Documentation & Audit Dossier Preparation

Axentra compiles regulator-ready comparator sourcing documentation packages used for dossier submission and audit defense:

Comparator sourcing justification statements
Licensed wholesaler certification records
Cold-chain logistics qualification documentation
Temperature monitoring logs and excursion assessments
Chain-of-custody flow diagrams
GDP compliance declarations
QA certification letters
Audit-ready comparator sourcing master files for ANDA, MAA, biosimilar dossiers
Regulatory inspection response support

Our documentation packages are designed to stand alone during regulatory inspection requests, minimizing sponsor exposure to sourcing-related findings.

GDP Compliance Oversight

This is Axentra’s primary value differentiator.

We function as an independent GDP compliance overlay across the comparator supply chain:

Supplier qualification and documentation verification for licensed wholesalers
Courier qualification and GDP logistics partner review
Storage condition verification and distribution compliance checks
Temperature monitoring data review
Chain-of-custody mapping from source to site delivery
Deviation and temperature excursion assessment documentation
Retrieval of corrective action statements from logistics partners where applicable
Complete distribution traceability compilation