Strategic planning for product development is the process of planning, organising and managing tasks and resources. These actions assure accomplishment of a well defined objective, usually within constraints of time, resources and costs.
To assist in this highly complex process SciencePharma can provide the following services:- determination of regulatory requirements in line with current directives and guidelines ,
- selection of necessary non-clinical and clinical trials and strategic planning for these studies,
- preparation of product development timelines indicating critical path, milestones and resources needed
- management of research and development projects, supervision of laboratories and subcontractors involved,
- in range of the research and development of the technological process of a new product:
- strategic planning of development studies in full range: from the idea/conception to the development of technology and analytics of the medicinal product in laboratory scale,
- development of specifications for active substances as well as for medicinal products according to current guidelines with the striving to reduce the costs of the quality control as much as possible,
- stability study design with the striving to reduce the costs of those studies,
- manufacturing process evaluation with cost optimization,
- research, screening and inspection of contractors,
- selection and supervision of product development contractors, including analytical, bioanalytical, formulation, process development, manufacturing and quality control
- full support for active substance and medicinal product manufacturers to:
- introduce GMP regulations (Good Manufacturing Practice),
- preparation for ISO certification,
- improvement of the substance/product quality,
- support with scale up of new and existing products,
- preparation or assessment of Drug Master Files (DMFs/EDMFs), technological documentation and quality documentation,
- solving problems with technology or analytics in: laboratory, pilot or production scale.
