Regulatory Filing /​answering

  • Development report – 3.2.p of ANDA dossier for filling
  •    Assist to answer the queries raised by regulatory agencies.
  • We do take 505(2)b filing in USA
  • We also do undertake ANDA/NDA/BLA
  • We undertake filings IP in all major Countries like UKMHRA,EMEA,TGA,ANVISA,etc.