Specialty Pharma division has an experienced regulatory team that works to aid customer requirements for development programs (DMF/CMC) as well as our global regulatory compliance needs for drug substance manufacturing.
Experienced regulatory staff with a track record of successful submissions
- Analytical Method Development to ICH guidelines
- Continuous improvement philosophy
- Fully analytical support including method development, method validation, stability studies
- Support customer development activities
- Preparation and maintenance of regulatory filings (DMF/CMC)
- Vendor audits
- Control documentation and testing
- Scientific and technical writing
- Comply with ICH Q7A
Effectiveness, safety and convenience of existing drugs and enhancing next-generation drug delivery is what we are constantly exploring.