Development
At SciencePharma, we provide development services for medicinal products (human and veterinary), medical devices, dietary supplements and cosmetics. We are distinguished by our experience in planning, organizing and managing complex pharmaceutical projects. We are proud of achieving many successes in that field. In each of the projects we lead, we identify its innovative, medical and scientific potential taking into account also the commercial aspects. Our experts can help investigate the shortest route and timeframe to place medical products on the market, and later-on support the Life Cycle Management of the products.
We invite to cooperation both pharmaceutical companies, as well as scientists. We can research and support any regulatory affairs projects, regardless of its size, complexity or the timeframe we have to work with.
The scope of SciencePharma development services includes:
At SciencePharma we provide development services for medicinal products (human and veterinary),
- Design of CMC research (chemical, manufacturing and controlling) – we provide services of planning and organization of R&D studies (including Quality by Design; QbD principles) at each step of the process – starting from coming up with a concept, through the analytics and technology development phase, and seeing everything through the laboratory, pilot and production stage. By using our services, you can also obtain information on practical aspects of the manufacture and get the support in analytical and technological troubleshooting.
- Design of Non-Clinical Studies (preclinical studies) and Clinical Trials to constitute the lowest possible expenditure, while being sufficient for successful product development and further dossier registration.
- Regulatory strategy (Regulatory roadmap) – we develop regulatory strategies based on current guidelines, recommendations and our experience, indicating the most efficient registration path together with listing all associated costs. 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.
- Project Gap analysis (Modules 1-5 assessment, if already available) – we are able to verify deficiencies within the project and suggest what studies or supplementary descriptions should be filled in the dossier.
- Regulatory Due Diligence – we assist our Clients in new product acquisitions by evaluating the product to identify potential disadvantages as well as obstacles which may be crucial for the commercialization of the product.
Comprehensive planning and management of R&D projects – we offer the opportunity to plan all the steps (CMC, nonclinical, clinical) necessary to design implementation, cost estimation and schedule optimization. We can also organize and manage the whole process to ensure that all tasks are timely and correctly executed. Being ahead of rapid regulatory changes in global and local markets enables us react quickly and modify the original project design as required – that also includes monitoring any changes to GxP requirements.