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.
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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.
- 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.
Process R&D Services
Pre- Formulation Studies
Analytical Support Services
Clinical Trials Services
Piramal Discovery Solutions (PDS) is a reputed service provider for mg to gm scale discovery chemistry. We have partnered with a range of well known pharmaceutical and biotechnology companies from Europe, USA and Japan.
We provide our enzyme catalyzed processes for fast track discovery and development of novel, green & economical routes to APIs.
Our capabilities harness the superior stereoselectivity, chemoselectivity and regioselectivity of Nature’s catalysts for the synthesis of complex molecules.
We have been providing pharmaceutical intermediate and API process development services for nearly three decades from our network of R∓D and manufacturing facilities across the globe. Our synergistic model of delivery across Canada, India and the UK offers the advantages of speedy drug development, proximity to markets, as well as flexible solutions. We have a team of over a hundred scientists across geographies supported by an infrastructure of fume-hoods, kilo labs, analytical instrumentation and GMP, as well as non-GMP production areas.
With very small quantities of active pharmaceutical ingredients (API) or drug-able candidate molecules, Piramal Pharma Solution’s pre-formulation service can provide valuable information and expertise to guide the compounds to next steps. Our pre-formulation team has extensive experience handling a wide range of compounds and can suggest the path forward for early success.
We offer Pharmaceutical Development Services for various dosage forms like Oral solids, Semi-Solids and Liquids (Sterile and Non-Sterile) from our facilities across UK and India. Being an integrated global solution provider we have the flexibility to simultaneously engage our facilities for conducting parallel development work to reduce the go-to-market time and costs for our customers
We offer a full range of analytical services, including analytical method development, validation and transfer, stability studies, comparator and in-process testing, from our state-of-the-art facilities and experienced scientific staff.
Piramal Corporate Regulatory Affairs, located in Mumbai, India provides expert clinical & regulatory support in all phases of global drug development programs. This includes regulatory support of New Chemical Entity’s development (NCE), Clinical Trials, Marketing products, Generics, OTC products & Medical devices
We offer specialized services in the area of Clinical Trial Supply management using our global network of assets, our experience and expertise in streamlining the clinical trial packaging and supply process, thus ensuring that the study drug is available where you need it and when you need it. Our advanced software, ‘Trak Pack®’, tracks the movement of the batch supplies across the supply chain.
Piramal facilities have the scientific capability and expertise to develop paediatric formulations meeting the age appropriate and regulatory requirements. We also offer Clinical Research Capabilities (CRO) to conduct Paediatric formulation screening studies to support scientific screening of various formulations during the development and selection stage.