The biggest challenge Pharma companies are facing is difficulty in increasing in Productivity in terms of quality efficiency and Innovation. Formulation is the process of combining the Chemicals, Excipient with the Active Pharmaceutical Ingredient (API) to prepare the finished dosage form either in the form of Solids, Semisolids or Liquids. Formulation Studies comprises of developing the dosage form which stable and easily accepted by the patients. The role of Formulation Manager is development of Pharmaceutical Product. He has to work in coordination with other departments like Manufacturing, QA, QC, and RA etc. and provide specified documentation to RA for ANDA Filings and Supplement Filings. All these challenges can be overcome by Chemia ELN Software.
Chemia ELN Software provides scientist to capture the data from the previously approved experiments. It helps the R&D team to exploit the knowledge. One of the powerful facilities of our Chemia ELN is cloning which assist in productivity improvement. It eliminates the legibility issues and enhances the collaboration between the teams. It also has similar search like Google search facility, which helps the scientists in searching the experiments, attachments related to experiments with the use of keywords. This search even helps in extracting reference documents that are attachment in the experiment with keyword. It is easily configurable and strictly 21 CFR Part 11 Compliance.
Our Chemia Formulation Development module provides the scientists the post formulation observations. It has ability to calculate the potency of active ingredients and calculate the manufacturing formula including excipients .It keeps a track of the ongoing experiments and helps to raise the analytical test request form to the Analytical Department.