Research & Development
Project Management
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 Hub Net Scientific Pharma:
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.
PROJECT ASSESSMENT AND ITS COMMERCIALIZATION
With many years of experience in the pharmaceutical industry, we offer consulting services in the field of assessing the potential of various projects, mainly related to the development of medicinal products, but also medical devices or dietary supplements. For each project we look for its innovative, medical and scientific potential as well as taking into account its commercial aspects. On the path to regulatory compliance, we identify areas where operations and processes can be improved with simple, cost-effective solutions, ensuring maximum quality and efficiency. By using of our services, you can also obtain information on practical aspects of the production. Thanks to the cooperation with Health-Med (www.health-med.pl/en) we can also help you in the drug product release in accordance with the GMP requirements in order to accelerate of medicinal products entrance on the market.
In our practice in a special way we take care of the confidentiality of the information, and therefore before starting of any activities we always sign a confidentiality agreement, and then conscientiously implement its provisions.
The most interesting projects we can also support from the financial side through advice on the selection financing or co-financing model and assistance in obtaining funds for their implementation
We invite to cooperation both pharmaceutical companies, as well as scientists. We can resource and support any regulatory affairs project, regardless of its size and timescale.
DESIGNING AND PLANNING OF R&D STUDIES
During project assessment we always think about commercialization of the results to be generated. In the case of medicinal products, product launch is preceded by the registration process when dossier containing physicochemical, non-clinical and clinical study results is evaluated. Registration agency experts have to assess the risk/benefit ratio for drug product which in turn determines whether the product can or cannot be placed on the market.
In Hub Net Scientific Pharma we always designing of R&D studies to comply with the registration requirements finding such an approach as optimal because reduces the risk of methodological errors and is timely and costly effective.
