Product Development services
At SciencePharma we have vast experience in product development, in planning, organizing and managing of complex pharmaceutical projects and we are proud of our successes. Our experts can help to investigate the shortest route and timeframe to place medicinal products and medical devices on the market, and later-on support the Life Cycle Management of these products.
The main tasks of our services include:
- Strategic analyses including preparation of product development roadmaps indicating possible scenarios, critical path, milestones, and resources needed,
- Development of a regulatory strategy based on current guidelines, recommendations and our experience,
- Comprehensive R&D project management – including Quality by Design principles; from idea to laboratory, pilot and final scale,
- Preparation of active substance and medicinal product specifications to minimize analytical costs,
- Assays design, design of stability studies, assessment of manufacturing process, design of validation protocols, support in analytical and technological troubleshooting,
- Design and organization of nonclinical and clinical studies,
- Selection and management of product development contractors, including analytical, bioanalytical, formulation, process development, manufacturing, quality control and drug product release,
- Finding of potential business partners including API and drug product contract manufacturers, analytical and bioanalytical laboratories, CROs for nonclinical and clinical trials,
- Plant inspections, introduction of EU GMP in third countries,
- CTD preparation and evaluation (Modules 1-5: administrative, quality, nonclinical and clinical documentation) for all kinds of application (original, generic, biosimilar, hybrid, bibliographic, FDC and traditional herbal medicinal products),
- Evaluation of dossier content (full or partial gap analysis),
- Experts support in registration procedures,
- Preparation of Scientific Advice briefing packages, organization and participation in the SA procedures in EU national agencies and in the European Medicines Agency (EMA).
0
Scientific strategic analyses concerning R&D plans in pharmaceutical sector
0
R&D projects – designed and managed (vast completed with positive CT results)