Dear Partners,

Necessitated by the unprecedented situation created by Covid-19, several industry events and tradeshows across the world have been postponed or stand cancelled. While we were looking forward to meet you, we at Piramal Pharma Solutions have had to take several precautionary measures to protect both our employees and customers, worldwide.

As we move forward in these extraordinary times, we want to assure you that that we are operational by taking the right safety measures and abundant precautions to ensure that we continue to support you and your patients.

While all of us are working remotely for now, you can schedule a discussion with us and we would be glad to help ensure you meet your pharmaceutical development and supply needs and thereby, your clinical and commercial timelines.

Please feel free to reach out to us at:

Our best wishes to colleagues, friends and family.

Best Regards,
Piramal Pharma Solutions

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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.