Quality
At SciencePharma we provide consulting services of CMC development involving pharmaceutical development (medicinal product studies design), Nitrosamines risk analysis, setting proper limits for organic and inorganic impurities, assessment of genotoxicity potential, stability study design and Quality dossier preparation.
Our widely experienced experts gladly advise on analytical method transfer for chemical, biological and biotechnological products, manufacturing process validation (taking into account EMA Guideline) and technology transfer.
As a professional GMP consultancy company, SciencePharma provides comprehensive services related to the GMP system implementation to pharmaceutical companies, assisting to obtain manufacturing or importation license and GMP certificate. Additionally, we provide also QP services including drug product certification. This combination of consulting and engineering services allows us to develop and implement seamless GMP and makes SciencePharma’s competences unique on the market.