Regulatory Services (ANDAs)
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
Below mentioned are detailed features of our services that we offer to different type of customers
- Filing of NDA / ANDAs in USA, MAs in Europe, Canada, Asia Pacific and Semi-regulated countries.
- Experience in regulatory filing of dosage forms including Immediate / Modified released solid dosage forms, parenterals (liquid, powder for injection), Nasal spray etc.
- ANDA / Generic Application with Paragraph I, II, III and IV certifications
- Experience in of filing ‘First to File’ generic applications
- Experience in of filing 505 (b) (2) application in the US
- Support Innovator Companies to writing sNDA / NDA’s (CMC Section-Module 1, 2 &3)
- Experience of review and compilation of Toxicology, Pharmacology and Clinical Sections (Module 4 &5)
- CTD / eCTD submissions with MRPs & DCP procedures in Europe.
- Post approval maintenance – submission of PAS, CBE 30/CBE, Annual Reports to US, Vairations to EU.
- Electronic Site registrations, GDUFA obligations like site identifications, Drug listing and SPL support for labeling for US.
- Vitamin dossiers supporting to food industry including food facility registration to US
IND / Clinical Trial Application
- IND expertise in compilation of CMC, pre-clinical and clinical review including regulatory development strategy.
- IND filing experience in US, Europe (France, Hungary, Czech, Netherlands), Australia, New Zealand, Argentina and India
- Total INDs filed by Piramal-38 No’s
- Phase I-19 No’s,
- Phase II-15 No’s,
- Phase III-3 No’s
- Phase IV-1 No.
- CTA (in Phase I and Phase II and III) filed in various countries in Europe, Canada, US and India.
- Three Herbal products are in phase-II / III clinical trial
- For clients (INDs filed by client) – JV with clients complete IND filing for co-development
- Phase I- 5 No’s
- Phase II- 2 No’s
Active Pharmaceutical Ingredients
- Experienced in filing DMFs, ASMFs and CEP’s / COS
- About 40 DMF’s and COS submitted in USA and Europe for supplying APIs to regulated markets
- Active DMFS in USA, Europe, Canada, Asia Pacific and semi-regulated countries (as applicable).
- CTD/eCTD submissions successfully done for EU,US, ROW countries.