Our products

Security of supply

While working on your Drug Substance, we will take care of the entire supply
chain for all the materials required to secure on-time production and delivery.

  • Well-established and controlled suppliers qualification process:
    • Paper Audit
    • Personal on-site Audit (For Intermediates and selected Regulatory Starting Materials)
    • Risk-based approach.
    • Managed by a separate QA Team dedicated to Suppliers Qualifications.
    • Own a Team of well-trained auditors. Auditors employed by Polpharma have a seat in Asia.
    • Periodic requalification (Every 3 years).
  • A broad network of reliable European suppliers qualified for solvents and basic
    chemicals that are in common use in API production.
  • Wide group of high-quality, GMP-compliant suppliers for Intermediates
    and Starting Materials qualified by Polpharma ready to produce custom
    intermediates on an exclusive basis.
  • Multipurpose lines give flexibility in planning and enable
    to implement your process in different lines as a contingency plan.
  • Experienced Regulatory affairs group supporting clients
    in CMC package preparation for filing