Regulatory Services

Piramal’s regulatory team, provides expert clinical & regulatory support through all phases of drug development. This includes regulatory support on New Chemical Entity’s (NCE), Clinical Trials, Marketing products, Generics, OTC products.

IND / Clinical Trial Application

  • IND expertise in compilation of CMC, pre-clinical and clinical review including regulatory development strategy.
  • IND and CTA (in Phase I and Phase II and III) filing experience in North America, Europe,South America, Asia Pacific .
  • Expertise in Orphan drug designation applications Development of Pre-IND meeting package to USFDA.
  • Total INDs filed by Piramal-38 No's
    Phase No. of INDs Filed
    I 19
    II 15
    III 3
    IV 1
  • For clients (INDs filed by client) – Joint Venture with clients complete IND filing for co-development
    Phase No. of INDs Filed
    I 5
    II 12

Active Pharmaceutical Ingredients

  • Experienced in filing DMFs, ASMFs and CEP's / COS.
  • Around 80 DMF/ASMF /JDMF and COS submitted for supplying APIs to regulated markets.
  • Active DMF in USA, Europe, Canada, Asia Pacific and semi-regulated countries (as applicable).
  • eCTD submissions successfully done for EU, US.
  • ASMFs submitted with all European countries in support of CP, DCP, NP, MRP and Work sharing procedures through CESP gateway.

Finished Formulations

  • Filing of NDA / ANDAs /MAs in USA,Canada,Europe, Asia Pacific and Semi-regulated countries.
  • Experience of filing dosage forms: Immediate / modified released solid dosage forms, parenteral (Liquid/Lyo), Fixed dose combination,Ophthalmic
  • Generic Application Paragraph II , III and IV with experience in “First to File”
  • Team collectively submitted more than 50 ANDAs of which more than 75% are approved and commercialized.Experience of filing 505 (b) (2) application in the US
  • Support Innovator Companies to writing sNDA / NDA (CMC Section-Module 1,2 & 3)
  • Post approval maintenance – PAS, CBE 30/CBE, Annual Reports to US, Variations to EU.
  • Vitamin dossiers supporting the food industry including food facility registration to US

e-Submissions and Publishing for both Active Pharmaceutical Ingredient and Finished Formulations

  • eCTD submissions successfully done for EU, US. CTD / eCTD submissions with MRPs & DCP procedures in Europe.
  • ASMFs submitted  with all  European  countries in support of CP,DCP, NP,MRP and Work sharing procedures through CESP gateway.
  • ANDAs, IND, MAs, Variations submitted electronically - SPL submission of finished formulation – NDC labels submitted with FDA through SPL.
  • Duns and establishment registration, self-identification for all sites for drugs and device.
  • Food facility registration for 2 sites under Bioterrorism Act For Food Facility Registration.