Regulatory affairs experience in generic and new drugs filing

  • 製薬(医療用医薬品)
  • 研究開発

経験内容

Almost 16 years of experience in R&D and regulatory affairs.
Have worked in generic pharma industry for development and successful filing of various dosage forms eg. Injectables & Solid oral dosage forms. Most of these products got approved as per timelines and few were NCE-1 filings too.
Have experience for US, Europe and some of emerging markets.
Have almost 5 years of experience in NCE filings for customers. Successfully supported development of drug substance & drug product and compiled CMC for INDs and IMPDs for phase I, II & III. Also provided same support for NDA & MAA filings of new drugs. All these molecules belong to small chemical molecule.