Effective management of multi-phase pharmaceutical projects is of key importance on the way to their successful implementation, especially when several partners/contractors are involved. We offer the opportunity to plan of all kinds of activities necessary to project implementation including cost and schedule optimisation. We can also organize and manage the whole process to ensure that all tasks are timely and correctly carried out. Due to the need to remain abreast of rapid regulatory changes in global and local markets and be up-to-date with GxP requirements, we are able to react appropriately, if modifications to the original project design are necessary.
Exemplary services offered by SciencePharma:
- Development of a regulatory strategy based on current guidelines, recommendations and our experience,
- Management of research and development studies including:
- comprehensive planning and organisation of R&D studies (including quality by design principles) starting from concept till analytics and technology development in laboratory, pilot and final scale,
- prepare specifications for the active substance and for the medicinal product minimizing of analytical costs,
- assays design and evaluation,
- cost-effective design of stability studies,
- assessment of manufacturing process and its optimisation, if necessary,
- review of production processes and advice on manufacturing strategy,
- support in analytical and technological troubleshooting,
- design of validation protocols,
- design and organisation of nonclinical and clinical studies,
- Preparation of development plans for the product indicating possible scenarios, critical stages and necessary resources,
- Development of project schedule and preliminary budget,
- Managing of research and development projects together with coordination of laboratories and subcontractors.
We are distinguished by our experience in planning, organizing and managing of complex pharmaceutical projects and we are proud of our successes (Experience). Our experts can help to investigate the shortest route and timeframe to place medical products on the market, and later-on support the Life Cycle Management of the products.