- Key technologies & expertise
- R&D Labs
- Manufacturing Plant
- Security of supply
- Quality control
- Project Management
Security of supply
While working on your Drug Substance we will take care of entire supply chain for all the materials required to secure on time production and delivery.
Well established and controlled suppliers qualification process:
Personal on site Audit (For Intermediates and selected Regulatory Starting Materials)
Risk based approach.
Managed by separate QA Team dedicated for Suppliers Qualification.
Own Team of well-trained auditors. Auditors employed by Polpharma having seat in Asia.
Periodic requalification (Every 3 years).
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 exclusive basis.
Multipurpose lines giving 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