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