Your products. Our concern.
PharOS operations and services within the product development sector are governed from the values of quality, safety and efficacy throughout all stages of the development process. PharOS’s confidence stems from our experts’ extensive exposure to various challenges and numerous accomplishments within the EU and the global pharmaceutical market, enabling us to fully support the following range of services:
• Selection of API manufacturer ensuring supply of patent-free drug substance of the highest production standards, following Qualified Person (QP) inspection of the facility and via thorough assessment of the quality documentation (DMF).
• Analytical method development and validation
• Design and Monitor of Pre-formulation and formulation trials for all dosage forms at a selected laboratory
• Selection of finished product (GMP certified) manufacturing site that integrates the effectiveness of the technology transfer, balances geographically the first commercial launch opportunities and accredits the reliability of the commercial supply.
• Design and monitor manufacture of validation batches and performance of stability testing.
• Selection of approved CRO and design of Bioequivalence study protocol
• Development Data Collection, Evaluation & Dossier Compilation
For us at PharOS, all stages of development are equally significant. By valuing every step and challenge, we are able to support our clients from the most simple to the most critical CMC and quality demands throughout the compilation of their pharmaceutical dossier.