Services Offered to Corporations:
- GMP and GLP audit and
corrective action support.
- Quality Systems and related documentation.
- Validation of process.
- Validation of analytical methods.
- Revamping of existing facilities.
- Developing analytical methods for impurity profile.
- Preparation of dossiers for submission to regulatory authorities.
- Training of technical staff.
- Organize studies in bio equivalence and bioavailability of
products.
- Improvement in productivity.
- Sourcing technology transfer.
- Guide to conduct studies in Stability Studies as per norms
of Regulatory Bodies.
Specialized Services and our expertise:
- Techno-economical feasibility
studies.
- Registration of sites and products in developing countries.
- Assisting in obtaining certificate of suitability for European
Commission.
- Conducting technical audit of site and products as per norms
of US FDA.
- Assisting and guiding in obtaining approvals in US FDA and
TGA.
- Regulatory compliance.
- To assist in formulating Standard Operating Procedures for
plant.
- To assist in modifying the layout of the plant as per requirement
of US FDA and TGA.
- Preparation of Drug Master Files for submission to regulatory
authorities.
- Help to achieve the desired objectives.
- Study and submit expert report for dossiers and Drug Master
Files for
- US FDA, European Commission and TGA
|
