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.
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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.