As international distributor, PISPO has developed a broad experience in regulatory and quality disciplines and it is proud to offer consultancy for the following services.
- Product registration and post marketing requirements in Europe
- Due diligence of pharmaceutical product dossiers and gap analysis
- Management of new projects or technology
- Transfers / optimization (re-formulation) of existing products
- Project feasibility assessment
- Selection of the best production technology / contract-manufacturer
- Sourcing of suitable components (API and excipients) and packaging
- Advice on all the steps of the project, from pre-formulation to pilot phase and industrialization
- Advice to set a proper validation plan (analytical, process, cleaning validations)
- Custom quality management system
- Complaint tracking management system
- Customer facing platform
For more information please contact firstname.lastname@example.org.