Activities for R&D development products
1-Develop any product with our partner R&D for all generic products include all dosage forms.
2-doing pilot scale in client plant.
3- Follow up the bioequivalence study
4-prepare/review the registration file for usFDA, EU, GCC…etc
5- Reply any notes received from regulatory.
6-troubleshooting for the products in development stage to get optimum formula.
6-sourcing for APIs.
7-modified for any formula for failed bioequivalence study to reach passed bioequivalence study.
8-trianing for formulation, analysis, and bioequivalence requirements.
9- Risk management for all process (eg.Manufacturing processes, Methodology etc.)
10- Evaluation formula before sending to Bioequivalence study.
11- Review registration file before send to regulatory EU/US/Gulf and MENA areas.
12- Provide the inhaler technology.
13- Development products in site the client plant /or in our partner R&D site.
14-Troubleshooting in both manufacturing process\ Analysis methodology.