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.